Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT01984294
Status:
COMPLETED
Last Update Posted:
2018-11-19
First Post:
2013-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C582393', 'term': 'GS-9669'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', '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 8 weeks plus 30 days', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks', 'otherNumAtRisk': 35, 'otherNumAffected': 24, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks', 'otherNumAtRisk': 32, 'otherNumAffected': 13, 'seriousNumAtRisk': 32, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks', 'otherNumAtRisk': 33, 'otherNumAffected': 23, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], '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': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}, {'value': '81.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants were randomized and received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: participants were randomized and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}], 'classes': [{'title': 'SVR2', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '97.0', 'groupId': 'OG002'}]}]}, {'title': 'SVR4', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}, {'value': '84.8', 'groupId': 'OG002'}]}]}, {'title': 'SVR8', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}, {'value': '81.8', 'groupId': 'OG002'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}, {'value': '81.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 2, 4, 8, and 24', 'description': 'SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA \\< LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing On-treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 weeks', 'description': 'On-treatment virologic failure was defined as\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)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Viral Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'OG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '18.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \\< LLOQ) at end of treatment, but did not achieve an SVR.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LDV/SOF+RBV', 'description': 'Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'FG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'FG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at a total of 1 study site in the United States. The first participant was screened on 29 October 2013. The last study visit occurred on 18 July 2014.', 'preAssignmentDetails': '117 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LDV/SOF+RBV', 'description': 'LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks'}, {'id': 'BG001', 'title': 'LDV/SOF+GS-9669 250 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks'}, {'id': 'BG002', 'title': 'LDV/SOF+GS-9669 500 mg', 'description': 'LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '57', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '57', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '57', 'spread': '8.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}, {'title': 'American Indian/ Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HCV Genotype', 'classes': [{'title': 'Genotype 1a', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Genotype 1b', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.', 'unitOfMeasure': 'participants'}, {'title': 'IL28b Status', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '0.50', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '0.63', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '0.57', 'groupId': 'BG002'}, {'value': '6.0', 'spread': '0.56', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'title': '< 800,000 IU/mL', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': '≥ 800,000 IU/mL', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants were randomized and received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2013-11-08', 'resultsFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-30', 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', '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) 12 weeks following the last dose of study drug.'}, {'measure': 'Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)', 'timeFrame': 'Posttreatment Weeks 2, 4, 8, and 24', 'description': 'SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA \\< LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.'}, {'measure': 'Percentage of Participants Experiencing On-treatment Virologic Failure', 'timeFrame': 'Up to 8 weeks', 'description': 'On-treatment virologic failure was defined as\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)'}, {'measure': 'Percentage of Participants Experiencing Viral Relapse', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \\< LLOQ) at end of treatment, but did not achieve an SVR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCV genotype 1', 'HCV', 'Sustained Virologic Response', 'Direct-Acting Antiviral', 'Combination Therapy', 'GS-7977', 'GS-5885', 'Ribavirin', 'Open Label', 'Sofosbuvir', 'Treatment-Naive', 'Protease Inhibitors', 'PI', 'Treatment experienced', 'Cirrhotic'], 'conditions': ['Chronic HCV Infection']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18, with chronic genotype 1 HCV infection\n* Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen\n* HCV RNA \\> 10,000 IU/mL at Screening\n* Presence of compensated cirrhosis\n* Screening laboratory values within defined thresholds\n* Use of two effective contraception methods if female of childbearing potential or sexually active male\n\nExclusion Criteria:\n\n* Pregnant or nursing female or male with pregnant female partner\n* Co-infection with HIV or hepatitis B virus (HBV)\n* Current or prior history of clinical hepatic decompensation\n* Chronic use of systemic immunosuppressive agents\n* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol'}, 'identificationModule': {'nctId': 'NCT01984294', 'briefTitle': 'Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-337-0133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDV/SOF+RBV', 'description': 'Participants will receive LDV/SOF plus RBV for 8 weeks.', 'interventionNames': ['Drug: LDV/SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'LDV/SOF + GS-9669 250 mg', 'description': 'Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.', 'interventionNames': ['Drug: LDV/SOF', 'Drug: GS-9669']}, {'type': 'EXPERIMENTAL', 'label': 'LDV/SOF + GS-9669 500 mg', 'description': 'Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.', 'interventionNames': ['Drug: LDV/SOF', 'Drug: GS-9669']}], 'interventions': [{'name': 'LDV/SOF', 'type': 'DRUG', 'otherNames': ['GS-7977/GS-5885'], 'description': 'Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily', 'armGroupLabels': ['LDV/SOF + GS-9669 250 mg', 'LDV/SOF + GS-9669 500 mg', 'LDV/SOF+RBV']}, {'name': 'RBV', 'type': 'DRUG', 'otherNames': ['Ribasphere®'], 'description': 'Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)', 'armGroupLabels': ['LDV/SOF+RBV']}, {'name': 'GS-9669', 'type': 'DRUG', 'description': 'GS-9669 tablet(s) administered orally once daily', 'armGroupLabels': ['LDV/SOF + GS-9669 250 mg', 'LDV/SOF + GS-9669 500 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Rob Hyland, DPhil', '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'}}}}