Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-02 @ 4:26 AM
Study NCT ID:
NCT03820258
Status:
TERMINATED
Last Update Posted:
2020-10-23
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654129', 'term': 'sofosbuvir velpatasvir voxilaprevir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose date up to the last dose date (maximum: 8 Weeks) plus 30 days', 'description': 'The Safety Analysis Set included participants received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'SOF', 'categories': [{'measurements': [{'value': '2474.8', 'spread': '1247.28', 'groupId': 'OG000'}]}]}, {'title': 'GS- 331007 (metabolite of SOF)', 'categories': [{'measurements': [{'value': '14890.2', 'spread': '3126.35', 'groupId': 'OG000'}]}]}, {'title': 'VEL', 'categories': [{'measurements': [{'value': '6773.0', 'spread': '2367.30', 'groupId': 'OG000'}]}]}, {'title': 'VOX', 'categories': [{'measurements': [{'value': '2205.8', 'spread': '1403.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sparse PK Sample (all participants): At Weeks 1 and 8 at any time, Weeks 2 and 4 (predose and between 15 minutes and 4 hours postdose). Intensive PK Sample [PK Substudy (N=14)]: Week 2 or Week 4 (0 (predose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose)', 'description': 'AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). For participants with separate consent to participate in the optional intensive PK substudy, intensive serial PK blood samples were collected at Week 2 or Week 4. Sparse PK samples were collected from all participants at Weeks 1, 2, 4, and end of treatment/Week 8. Plasma concentration data from all PK samples (intensive and sparse) were combined and used to generate PK parameters of SOF, GS-331007, VEL, and VOX for all participants using a population PK modeling approach.', 'unitOfMeasure': 'hours•nanogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic Analysis Set included all enrolled adolescent participants who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value was available from all types of PK sampling.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to the last dose date (maximum: 8 Weeks) plus 30 days', 'description': 'Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of study drug. It also includes the AEs that leads to premature discontinuation of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR was defined as hepatitis C virus (HCV RNA) \\< Lower limit of quantification (LLOQ) (ie, \\< 15 IU/mL) 12 weeks after discontinuation of the study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all adolescent participants 12 to \\< 18 years old who were enrolled into the study and took at least 1 dose of study drug (SOF/VEL/VOX FDC).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR was defined as HCV RNA \\< LLOQ (ie, \\< 15 IU/mL) 4 weeks after discontinuation of the study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ 24 Weeks After Discontinuation of Therapy (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR was defined as HCV RNA \\< LLOQ (ie, \\< 15 IU/mL) 24 weeks after discontinuation of the study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Overall Virologic Failure comprises of on-treatment virologic failure and relapse. On-treatment virologic failure (breakthrough, rebound, and nonresponse) and relapse were defined as follows: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), Rebound (confirmed \\> 1 log10IU/mL increase in HCV RNA from nadir while on treatment), or Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) and Relapse (confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on treatment visit).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '29.8', 'upperLimit': '74.3'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '58.1', 'upperLimit': '94.6'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '69.6', 'upperLimit': '98.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 4, and 8', 'description': 'Percentage of participants with HCV RNA \\< LLOQ (15 IU/mL) while on treatment by analysis visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to End of Treatment (Week 8)', 'description': 'Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome. No on-treatment virologic breakthrough or relapse was observed. Therefore, no participants qualified for resistance testing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome. No on-treatment virologic breakthrough or relapse was observed through posttreatment Week 12 or posttreatment Week 24.'}, {'type': 'SECONDARY', 'title': 'Change in HCV RNA From Day 1 Through End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.55', 'spread': '0.525', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'spread': '0.621', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.71', 'spread': '0.661', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.77', 'spread': '0.698', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1); Weeks 1, 2 ,4, and 8', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Alanine Aminotransferase (ALT) Normalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'FU-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1); Week 1, 2, 4, 8, and Posttreatment/Follow-up Week 4 (FU-4)', 'description': 'ALT normalization was defined as ALT \\> upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed. It includes participants with ALT \\>ULN at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height Percentiles as a Measurement of Growth and Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '63.2'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '1.3'}]}]}, {'title': 'Change at FU-12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '3.8'}]}]}, {'title': 'Change at FU-24', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1); Weeks 1, 2, 4, 8, FU-4, Posttreatment/Follow-up Week 12 (FU-12), and Posttreatment/Follow-up Week 24 (FU-24)', 'description': 'An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight Percentiles as a Measurement of Growth and Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '75.9'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-1.2'}]}]}, {'title': 'Change at FU-12', 'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-7.1', 'upperLimit': '0.3'}]}]}, {'title': 'Change at FU-24', 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1); Weeks 1, 2, 4, 8, FU-4, FU-12, and FU-24', 'description': 'An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Pubic Hair (Male); Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Male); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Male); FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Male); FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Genitalia (Male); Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Genitalia (Male); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Genitalia (Male); FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Genitalia (Male); FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Female); Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Female); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Female); FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Pubic Hair (Female); FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Breasts (Female); Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Breasts (Female); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Breasts (Female); FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Breasts (Female); FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 5', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1); Weeks 8, FU-12, and FU-24', 'description': 'Tanner Pubertal Staging were assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages will be used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed.Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum and testes, Penis (10.5-12.5); 3: Enlargement of penis (11.5-14); 4: Penis size (13.5-15); 5: Genitalia adult in size and shape).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Radiographic Bone Age Assessment as a Measurement of Growth and Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '16.0'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1); Week 8', 'description': 'For radiographic bone age assessment, a single x-ray of the left wrist, hand, and fingers was performed and assessed by changes from baseline through end of treatment period.', 'unitOfMeasure': 'years', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '2.35'}]}]}, {'title': 'Change at FU-24', 'categories': [{'measurements': [{'value': '-0.22', 'groupId': 'OG000', 'lowerLimit': '-0.55', 'upperLimit': '-0.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1); FU-24', 'description': 'Fasting blood samples for baseline values for bone age biomarkers CTX and change from baseline were recorded.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '383.25', 'groupId': 'OG000', 'lowerLimit': '175.00', 'upperLimit': '944.20'}]}]}, {'title': 'Change at FU-24', 'categories': [{'measurements': [{'value': '-101.50', 'groupId': 'OG000', 'lowerLimit': '-359.00', 'upperLimit': '-24.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1); FU-24', 'description': 'Fasting blood samples for baseline values for bone age biomarkers P1NP and change from baseline were recorded.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Swallowability Category of Able to Swallow or Unable to Swallow SOF/VEL/VOX 400/100/100 mg Size Tablets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Able to Swallow PTM Tablet', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to Swallow PTM Tablet', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1)', 'description': 'Swallowability for SOF/VEL/VOX FDC placebo to match (PTM) tablets was summarized based on the participants present in each swallowability category of Able to Swallow or Unable to Swallow a placebo tablet on one occasion during screening until Day 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Did Not Taste Study Drug; Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Very Bad); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Bad); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Maybe Bad/ Maybe Good); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Good); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Very Good); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Very Hard); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Hard); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Maybe Hard/ Maybe Easy); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Easy); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Very Easy); Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'Did Not Taste Study Drug; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Very Bad); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Bad); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Maybe Bad/ Maybe Good); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Good); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Very Good); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Very Hard); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Hard); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Maybe Hard/ Maybe Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Very Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Very Hard); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Hard); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Maybe Hard/Maybe Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Very Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets(Very Hard); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets(Hard); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets( Maybe Hard/ Maybe Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets(Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets(Very Easy); Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1); Week 8', 'description': 'A questionnaire was administered to participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, and also at the end of treatment about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Did Not Taste Study Drug', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Very Bad)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Bad)', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Maybe Bad/ Maybe Good)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Good)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Taste (Very Good)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Very Hard)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Hard)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Maybe Hard/ Maybe Easy)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Easy)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Swallow (Very Easy)', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}]}]}, {'title': 'Take (Very Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Hard)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Take (Maybe Hard/ Maybe Easy)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}]}]}, {'title': 'Take (Easy)', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'Take (Very Easy)', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets (Very Hard)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets (Hard)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets (Maybe Hard/Maybe Easy)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets (Easy)', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000'}]}]}, {'title': 'Number of Tablets (Very Easy)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'A questionnaire was administered to the parent/legal guardian of participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Physical Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.1', 'spread': '17.06', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.29', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '6.40', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.0', 'spread': '19.33', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '21.43', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '18.56', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.0', 'spread': '10.95', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '8.67', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '6.88', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.2', 'spread': '22.89', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '18.37', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '16.15', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.1', 'spread': '17.06', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health ; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.29', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '6.40', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.6', 'spread': '15.04', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '12.38', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '11.51', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.1', 'spread': '14.13', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '9.32', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '8.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better health-related quality of life (HRQOL). A positive change from end of treatment period indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Physical Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.4', 'spread': '17.29', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.39', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '12.97', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.6', 'spread': '21.06', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '22.53', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '17.95', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.7', 'spread': '17.80', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '18.04', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '14.41', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '27.63', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '20.84', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '16.77', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.4', 'spread': '17.29', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health ; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.39', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '12.97', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'spread': '17.46', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '15.82', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.61', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.5', 'spread': '16.10', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '12.67', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '7.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from end of treatment period indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Assessments as Completed by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Physical Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.7', 'spread': '13.81', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '10.20', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '11.87', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '12.72', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.2', 'spread': '20.07', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '10.63', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '19.78', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '15.64', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '12.53', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '9.16', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '10.17', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '8.70', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '24.58', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '17.97', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '12.21', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '11.06', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.7', 'spread': '13.81', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '10.20', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '11.87', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health, Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '12.72', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.8', 'spread': '14.16', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '7.47', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.74', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '8.81', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.4', 'spread': '12.40', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '5.30', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '8.83', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '8.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1); Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It was presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'classes': [{'title': 'Physical Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.3', 'spread': '22.56', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '20.97', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '20.90', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '19.97', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '18.57', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '18.57', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '14.50', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '12.80', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.8', 'spread': '18.36', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '21.84', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '18.39', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '21.27', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.5', 'spread': '27.59', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '23.64', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '22.80', 'groupId': 'OG000'}]}]}, {'title': 'School Functioning; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '20.50', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.3', 'spread': '22.56', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '20.97', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '20.90', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health, Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '19.97', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.8', 'spread': '17.34', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '17.39', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '15.31', 'groupId': 'OG000'}]}]}, {'title': 'Psychosocial Health; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '15.52', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.7', 'spread': '15.40', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '15.84', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '14.37', 'groupId': 'OG000'}]}]}, {'title': 'Total Score; Change at FU-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '14.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1); Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Europe. The first participant was screened on 28 January 2019. The last study visit occurred on 19 February 2020.', 'preAssignmentDetails': 'The study was terminated because EMA granted Gilead a waiver for SOF/VEL/VOX in children less than 12 years old. Cohorts 2 and 3 were not enrolled. As per the protocol, participants could have received 8 or 12 weeks of treatment, depending on their prior treatment and disease status, however all participants received treatment for 8 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF/VEL/VOX FDC', 'description': 'Direct-acting antiviral (DAA) - naive participants without cirrhosis (12 to \\< 18 years old) received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose (FDC) combination (400/100/100 mg tablet) orally once daily in nonfasting state for 8 weeks. A single placebo to match tablet was administered during screening until Day 1 to confirm the participant was able to swallow SOF/VEL/VOX 400/100/100 mg tablets.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Cirrhosis', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HCV Ribonucleic acid (RNA)', 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '0.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Alanine aminotransferase (ALT) Category', 'classes': [{'categories': [{'title': '≤ 1.5 x (Upper Limit of Normal) ULN', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '> 1.5 x ULN', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-10', 'size': 1425586, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-20T09:50', 'hasProtocol': False}, {'date': '2019-03-27', 'size': 4179505, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-31T02:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'SOF/VEL/VOX will not be evaluated in younger age groups.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2019-01-14', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-13', 'studyFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter: AUCtau of SOF, GS-331007 (Metabolite of SOF), VEL, and VOX', 'timeFrame': 'Sparse PK Sample (all participants): At Weeks 1 and 8 at any time, Weeks 2 and 4 (predose and between 15 minutes and 4 hours postdose). Intensive PK Sample [PK Substudy (N=14)]: Week 2 or Week 4 (0 (predose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours postdose)', 'description': 'AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). For participants with separate consent to participate in the optional intensive PK substudy, intensive serial PK blood samples were collected at Week 2 or Week 4. Sparse PK samples were collected from all participants at Weeks 1, 2, 4, and end of treatment/Week 8. Plasma concentration data from all PK samples (intensive and sparse) were combined and used to generate PK parameters of SOF, GS-331007, VEL, and VOX for all participants using a population PK modeling approach.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event', 'timeFrame': 'First dose date up to the last dose date (maximum: 8 Weeks) plus 30 days', 'description': 'Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of study drug. It also includes the AEs that leads to premature discontinuation of study drug.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR was defined as hepatitis C virus (HCV RNA) \\< Lower limit of quantification (LLOQ) (ie, \\< 15 IU/mL) 12 weeks after discontinuation of the study drug.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ 4 Weeks After Discontinuation of Therapy (SVR4)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR was defined as HCV RNA \\< LLOQ (ie, \\< 15 IU/mL) 4 weeks after discontinuation of the study drug.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ 24 Weeks After Discontinuation of Therapy (SVR24)', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR was defined as HCV RNA \\< LLOQ (ie, \\< 15 IU/mL) 24 weeks after discontinuation of the study drug.'}, {'measure': 'Percentage of Participants With Overall Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Overall Virologic Failure comprises of on-treatment virologic failure and relapse. On-treatment virologic failure (breakthrough, rebound, and nonresponse) and relapse were defined as follows: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), Rebound (confirmed \\> 1 log10IU/mL increase in HCV RNA from nadir while on treatment), or Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) and Relapse (confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on treatment visit).'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ on Treatment', 'timeFrame': 'Weeks 1, 2, 4, and 8', 'description': 'Percentage of participants with HCV RNA \\< LLOQ (15 IU/mL) while on treatment by analysis visit.'}, {'measure': 'Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX During Treatment', 'timeFrame': 'Up to End of Treatment (Week 8)', 'description': 'Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure.'}, {'measure': 'Percentage of Participants Who Developed Viral Resistance to SOF, VEL, and/or VOX When Treatment is Discontinued', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Plasma samples were collected and stored for potential HCV sequencing. Impact on the treatment outcomes of SVR12 and SVR24 were observed during the study. Baseline nonstructural protein (NS)3, NS5A, and NS5B deep sequencing analysis was performed for all participants. Sequencing for the HCV NS5A and NS5B regions was performed for all enrolled participants at baseline and for participants with virologic failure.'}, {'measure': 'Change in HCV RNA From Day 1 Through End of Treatment', 'timeFrame': 'Baseline (Day 1); Weeks 1, 2 ,4, and 8'}, {'measure': 'Percentage of Participants With Alanine Aminotransferase (ALT) Normalization', 'timeFrame': 'Baseline (Day 1); Week 1, 2, 4, 8, and Posttreatment/Follow-up Week 4 (FU-4)', 'description': 'ALT normalization was defined as ALT \\> upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.'}, {'measure': 'Change From Baseline in Height Percentiles as a Measurement of Growth and Development', 'timeFrame': 'Baseline (Day 1); Weeks 1, 2, 4, 8, FU-4, Posttreatment/Follow-up Week 12 (FU-12), and Posttreatment/Follow-up Week 24 (FU-24)', 'description': 'An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.'}, {'measure': 'Change From Baseline in Weight Percentiles as a Measurement of Growth and Development', 'timeFrame': 'Baseline (Day 1); Weeks 1, 2, 4, 8, FU-4, FU-12, and FU-24', 'description': 'An age- and sex-specific percentile was derived for each weight, height, and body mass index (BMI) measurement according to the statistical analysis system (SAS) program available on the Centers for Disease Control and Prevention (CDC) website using the year 2000 growth charts.'}, {'measure': 'Number of Participants by Tanner Stage Assessment as a Measurement of Growth and Development', 'timeFrame': 'Baseline (Day 1); Weeks 8, FU-12, and FU-24', 'description': 'Tanner Pubertal Staging were assessed for pubic hair growth and genitalia development (males) and for pubic hair growth and breast development (females) in stages 1 to 5. Tanner stages will be used to evaluate the onset and progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed.Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to medial surface of the thighs); Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts); Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum and testes, Penis (10.5-12.5); 3: Enlargement of penis (11.5-14); 4: Penis size (13.5-15); 5: Genitalia adult in size and shape).'}, {'measure': 'Change From Baseline in Radiographic Bone Age Assessment as a Measurement of Growth and Development', 'timeFrame': 'Baseline (Day 1); Week 8', 'description': 'For radiographic bone age assessment, a single x-ray of the left wrist, hand, and fingers was performed and assessed by changes from baseline through end of treatment period.'}, {'measure': 'Change From Baseline in C-Type Collagen Sequence (CTX) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development', 'timeFrame': 'Baseline (Day 1); FU-24', 'description': 'Fasting blood samples for baseline values for bone age biomarkers CTX and change from baseline were recorded.'}, {'measure': 'Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP) Bone Turn-Over Biochemical Marker as a Measurement of Growth and Development', 'timeFrame': 'Baseline (Day 1); FU-24', 'description': 'Fasting blood samples for baseline values for bone age biomarkers P1NP and change from baseline were recorded.'}, {'measure': 'Percentage of Participants in Each Swallowability Category of Able to Swallow or Unable to Swallow SOF/VEL/VOX 400/100/100 mg Size Tablets', 'timeFrame': 'Baseline (Day 1)', 'description': 'Swallowability for SOF/VEL/VOX FDC placebo to match (PTM) tablets was summarized based on the participants present in each swallowability category of Able to Swallow or Unable to Swallow a placebo tablet on one occasion during screening until Day 1.'}, {'measure': 'Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Study Participant', 'timeFrame': 'Baseline (Day 1); Week 8', 'description': 'A questionnaire was administered to participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, and also at the end of treatment about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow.'}, {'measure': 'Percentage of Participants With Acceptability Questionnaire Responses as Assessed by the Parent/Legal Guardian', 'timeFrame': 'Week 8', 'description': 'A questionnaire was administered to the parent/legal guardian of participants to assess acceptability, including palatability, of the formulation. Acceptability and palatability were assessed by questions about how the study drug tasted, how easy it was to swallow the study drug, about how it was to take the study drug and, as they all received a single tablet daily, how they felt about the number of tablets they had to swallow.'}, {'measure': 'Neuropsychiatric Assessments Based on Questionnaire as Completed by Participant', 'timeFrame': 'Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better health-related quality of life (HRQOL). A positive change from end of treatment period indicates improvement.'}, {'measure': 'Neuropsychiatric Assessments Based on Questionnaire as Completed by Parent/Legal Guardian', 'timeFrame': 'Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from end of treatment period indicates improvement.'}, {'measure': 'Change From Baseline in Neuropsychiatric Assessments as Completed by Participant', 'timeFrame': 'Baseline (Day 1); Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by all the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It was presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Neuropsychiatric Assessments as Completed by Parent/Legal Guardian', 'timeFrame': 'Baseline (Day 1); Weeks 8, FU-12, and FU-24', 'description': 'Neuropsychiatric safety assessment was done using the Pediatric Quality of Life (PedsQL™ 4.0 SF15). The PedsQL™ 4.0 SF15 Questionnaires was completed by the parent/ legal guardian of the participants. It is a comprehensive and widely used patient-reported outcome survey designed to measure health-related quality of life in healthy children and adolescents. It is presented for each of the 4 domains of the SF-15 (physical functioning, emotional functioning, social functioning, and school functioning), the psychosocial health summary (emotional, social, and school functioning domains), physical health summary and the Total Score. Total scores as well as each of the subscale scores are transformed on a scale from 0 to 100. Higher scores in each case indicate better HRQOL. A positive change from baseline indicates improvement.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.', 'detailedDescription': 'Participants will receive placebo to match SOF/VEL/VOX FDC to assess ability to swallow tablets at screening up to Day 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Consent of parent or legal guardian required\n* Chronic HCV infection\n* Screening laboratory values within defined thresholds\n* Individuals must have a determination of prior treatment status:\n\n * DAA-naive is defined as either:\n\n * Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA\n * Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA\n * DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)\n\nKey Exclusion Criteria:\n\n* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol\n* Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)\n* Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)\n* Pregnant or nursing females\n* Known hypersensitivity to study medication\n* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03820258', 'briefTitle': 'Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children With Chronic HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-367-1175'}, 'secondaryIdInfos': [{'id': '2018-000480-87', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 1 (12 to < 18 years old), 8 Weeks', 'description': 'Direct-acting antiviral (DAA)-naive participants without cirrhosis in Cohort 1 (12 to \\< 18 years old) will receive SOF/VEL/VOX FDC 400/100/100 mg for 8 weeks.', 'interventionNames': ['Drug: SOF/VEL/VOX']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 1 (12 to < 18 years old), 12 Weeks', 'description': 'DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 1 (12 to \\< 18 years old) will receive SOF/VEL/VOX FDC 400/100/100 mg for 12 weeks.', 'interventionNames': ['Drug: SOF/VEL/VOX']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 2 (6 to < 12 years old), 8 Weeks', 'description': 'DAA-naive participants without cirrhosis in Cohort 2 (6 to \\< 12 years old) will receive SOF/VEL/VOX FDC for 8 weeks.', 'interventionNames': ['Drug: SOF/VEL/VOX']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 2 (6 to < 12 years old), 12 Weeks', 'description': 'DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 2 (6 to \\< 12 years old) will receive SOF/VEL/VOX FDC for 12 weeks.', 'interventionNames': ['Drug: SOF/VEL/VOX']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 3 (3 to < 6 years old), 8 Weeks', 'description': 'DAA-naive participants without cirrhosis in Cohort 3 (6 to \\< 12 years old) will receive SOF/VEL/VOX FDC for 8 weeks.', 'interventionNames': ['Drug: SOF/VEL/VOX']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort 3 (3 to < 6 years old), 12 Weeks', 'description': 'DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 3 (3 to \\< 6 years old) will receive SOF/VEL/VOX FDC for 12 weeks.', 'interventionNames': ['Drug: SOF/VEL/VOX']}], 'interventions': [{'name': 'SOF/VEL/VOX', 'type': 'DRUG', 'otherNames': ['Vosevi ®'], 'description': 'Administered once daily with food.', 'armGroupLabels': ['Experimental: Cohort 1 (12 to < 18 years old), 12 Weeks', 'Experimental: Cohort 1 (12 to < 18 years old), 8 Weeks', 'Experimental: Cohort 2 (6 to < 12 years old), 12 Weeks', 'Experimental: Cohort 2 (6 to < 12 years old), 8 Weeks', 'Experimental: Cohort 3 (3 to < 6 years old), 12 Weeks', 'Experimental: Cohort 3 (3 to < 6 years old), 8 Weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'SOS-intraSOC Epatologia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Servizio di Epatologia e Nutrizione Pediatrica', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'US Infettivologia Pediatrica-Polo Universitario', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'UOS Epatologia Pediatrica', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'country': 'Italy', 'facility': 'UOSD Epatologia', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '85-030', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Wojewodzki Szpital', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '60-693', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Med Polonia', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '50-368', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny im.', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Women's and Children's NHS Foundation Trust", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings Healthcare NHS Trust Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '18 months after study completion', 'ipdSharing': 'YES', 'description': 'Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}