Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-25 @ 5:21 PM
Study NCT ID:
NCT02738333
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 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': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}, {'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, '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': 'Up to 12 weeks plus 30 days', 'description': 'Safety Analysis Set: participants who took at least 1 dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 25, 'seriousNumAtRisk': 106, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 48, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '99.0'}, {'value': '95.4', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '98.5'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '79.6', 'upperLimit': '99.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '7.1', 'estimateComment': 'Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.'}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants who were randomized and took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '92.0', 'upperLimit': '99.4'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '93.5', 'upperLimit': '99.8'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '79.6', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '99.0'}, {'value': '95.4', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '98.5'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '79.6', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR 24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '33.8'}, {'value': '31.5', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '41.1'}, {'value': '32.0', 'groupId': 'OG002', 'lowerLimit': '14.9', 'upperLimit': '53.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '81.7'}, {'value': '76.6', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '84.3'}, {'value': '76.0', 'groupId': 'OG002', 'lowerLimit': '54.9', 'upperLimit': '90.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '95.4'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '83.5', 'upperLimit': '95.4'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '79.6', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '93.4', 'upperLimit': '99.8'}, {'value': '96.3', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '99.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '99.8'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '94.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '100.0'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '94.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '86.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.18', 'spread': '0.540', 'groupId': 'OG000'}, {'value': '-4.34', 'spread': '0.602', 'groupId': 'OG001'}, {'value': '-4.24', 'spread': '0.550', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 1', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.76', 'spread': '0.759', 'groupId': 'OG000'}, {'value': '-4.81', 'spread': '0.772', 'groupId': 'OG001'}, {'value': '-4.64', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 2', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.87', 'spread': '0.780', 'groupId': 'OG000'}, {'value': '-4.89', 'spread': '0.790', 'groupId': 'OG001'}, {'value': '-4.75', 'spread': '0.714', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 3', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.89', 'spread': '0.782', 'groupId': 'OG000'}, {'value': '-4.91', 'spread': '0.794', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.91', 'spread': '0.781', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '0.794', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 5', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.91', 'spread': '0.781', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '0.793', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 6', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.92', 'spread': '0.785', 'groupId': 'OG000'}, {'value': '-4.93', 'spread': '0.794', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 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': 'Change From Baseline in HCV RNA at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.92', 'spread': '0.785', 'groupId': 'OG000'}, {'value': '-4.93', 'spread': '0.794', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 10', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.92', 'spread': '0.785', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '0.794', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '0.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', '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 Overall Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'OG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * 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': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks'}, {'id': 'FG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'FG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Japan. The first participant was screened on 12 April 2016. The last study visit occurred on 11 May 2017.', 'preAssignmentDetails': '266 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks'}, {'id': 'BG001', 'title': 'SOF+RBV (Cohort 1)', 'description': 'SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks'}, {'id': 'BG002', 'title': 'LDV/SOF (Cohort 2)', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '60', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '74', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '61', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IL28b Status', 'classes': [{'categories': [{'title': 'CC', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}, {'title': 'CT', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'TT', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA (log10 IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '0.79', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '0.79', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '0.72', 'groupId': 'BG002'}, {'value': '6.0', 'spread': '0.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '163', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: participants who took at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-22', 'size': 1874622, 'label': 'Study Protocol: Original', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-24T16:39', 'hasProtocol': True}, {'date': '2016-01-27', 'size': 1875696, 'label': 'Study Protocol: Amendment 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_005.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-24T16:39', 'hasProtocol': True}, {'date': '2016-02-23', 'size': 1914060, 'label': 'Study Protocol: Amendment 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-24T16:40', 'hasProtocol': True}, {'date': '2017-02-21', 'size': 1163596, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-24T16:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2016-04-11', 'resultsFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-12', 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR 24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 1', 'timeFrame': 'Week 1'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 2', 'timeFrame': 'Week 2'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 3', 'timeFrame': 'Week 3'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 5', 'timeFrame': 'Week 5'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 6', 'timeFrame': 'Week 6'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 8', 'timeFrame': 'Week 8'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 10', 'timeFrame': 'Week 10'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ at Week 12', 'timeFrame': 'Week 12'}, {'measure': 'Change From Baseline in HCV RNA at Week 1', 'timeFrame': 'Baseline; Week 1'}, {'measure': 'Change From Baseline in HCV RNA at Week 2', 'timeFrame': 'Baseline; Week 2'}, {'measure': 'Change From Baseline in HCV RNA at Week 3', 'timeFrame': 'Baseline; Week 3'}, {'measure': 'Change From Baseline in HCV RNA at Week 4', 'timeFrame': 'Baseline; Week 4'}, {'measure': 'Change From Baseline in HCV RNA at Week 5', 'timeFrame': 'Baseline; Week 5'}, {'measure': 'Change From Baseline in HCV RNA at Week 6', 'timeFrame': 'Baseline; Week 6'}, {'measure': 'Change From Baseline in HCV RNA at Week 8', 'timeFrame': 'Baseline; Week 8'}, {'measure': 'Change From Baseline in HCV RNA at Week 10', 'timeFrame': 'Baseline; Week 10'}, {'measure': 'Change From Baseline in HCV RNA at Week 12', 'timeFrame': 'Baseline; Week 12'}, {'measure': 'Percentage of Participants With Overall Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females\n* Aged 20 years or older\n* Treatment naive or treatment experienced\n* At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.\n\nKey Exclusion Criteria:\n\n* Previous exposure to an NS5A or NS5B inhibitor\n* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)\n* Pregnant or nursing female or male with pregnant female partner\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02738333', 'briefTitle': 'Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-337-1903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDV/SOF (Cohort 1)', 'description': 'LDV/SOF FDC for 12 weeks', 'interventionNames': ['Drug: LDV/SOF']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+RBV (Cohort 1)', 'description': 'SOF+RBV for 12 weeks', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'LDV/SOF (Cohort 2)', 'description': 'Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.', 'interventionNames': ['Drug: LDV/SOF']}], 'interventions': [{'name': 'LDV/SOF', 'type': 'DRUG', 'otherNames': ['Harvoni®', 'GS-5885/GS-7977'], 'description': '90/400 mg FDC tablet administered orally once daily', 'armGroupLabels': ['LDV/SOF (Cohort 1)', 'LDV/SOF (Cohort 2)']}, {'name': 'SOF', 'type': 'DRUG', 'otherNames': ['Sovaldi®', 'GS-7977', 'PSI-7977'], 'description': '400 mg tablet administered orally once daily', 'armGroupLabels': ['SOF+RBV (Cohort 1)']}, {'name': 'RBV', 'type': 'DRUG', 'otherNames': ['REBETOL®'], 'description': 'Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \\> 60 kg to ≤ 80 kg = 800 mg, and \\> 80 kg = 1000 mg)', 'armGroupLabels': ['SOF+RBV (Cohort 1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bunkyō City', 'country': 'Japan', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chūō', 'country': 'Japan', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'city': 'Ehime', 'country': 'Japan'}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuyama', 'country': 'Japan', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Ikeda', 'country': 'Japan', 'geoPoint': {'lat': 34.82208, 'lon': 135.4298}}, {'city': 'Iruma-gun', 'country': 'Japan'}, {'city': 'Izunokuni', 'country': 'Japan', 'geoPoint': {'lat': 35.03907, 'lon': 138.95143}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kashihara', 'country': 'Japan', 'geoPoint': {'lat': 34.58333, 'lon': 135.61667}}, {'city': 'Kitakyushu', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maebashi', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Matsumoto', 'country': 'Japan', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Morioka', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Musashino', 'country': 'Japan', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nagoya', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nishinomiya', 'country': 'Japan', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōgaki', 'country': 'Japan', 'geoPoint': {'lat': 35.35, 'lon': 136.61667}}, {'city': 'Ōmura', 'country': 'Japan', 'geoPoint': {'lat': 32.92139, 'lon': 129.95389}}, {'city': 'Saga', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Sagamihara', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Sapporo', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sendai', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Suita', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'tabashi City', 'country': 'Japan', 'geoPoint': {'lat': 35.74893, 'lon': 139.71497}}, {'city': 'Takamatsu', 'country': 'Japan', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Ube', 'country': 'Japan', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'city': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Yufu', 'country': 'Japan', 'geoPoint': {'lat': 33.1956, 'lon': 131.37829}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'http://www.gilead.com/research/disclosure-and-transparency', '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 http://www.gilead.com/research/disclosure-and-transparency.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}