Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT01965535
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2013-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}]}}, '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}, 'limitationsAndCaveats': {'description': 'There were no limitations affecting the analysis or results.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks plus 30 days', 'description': 'Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks', 'otherNumAtRisk': 78, 'otherNumAffected': 67, 'seriousNumAtRisk': 78, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks', 'otherNumAtRisk': 77, 'otherNumAffected': 72, 'seriousNumAtRisk': 77, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cranial nerve infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], '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': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '96.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '8.6', 'estimateComment': 'The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.', 'groupDescription': 'A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, \\< 25 IU/mL) 12 weeks following the last dose of study drug.\n\n* 1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.\n* 1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '96.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 were defined as HCV RNA \\< LLOQ at 4 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 With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, and 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}], 'classes': [{'title': 'Week 1 (LDV/SOF: n = 75; LDV/SOF + RBV: n = 75)', 'categories': [{'measurements': [{'value': '-4.10', 'spread': '0.558', 'groupId': 'OG000'}, {'value': '-4.27', 'spread': '0.547', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)', 'categories': [{'measurements': [{'value': '-4.74', 'spread': '0.926', 'groupId': 'OG000'}, {'value': '-4.94', 'spread': '0.452', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)', 'categories': [{'measurements': [{'value': '-5.10', 'spread': '0.582', 'groupId': 'OG000'}, {'value': '-5.19', 'spread': '0.433', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)', 'categories': [{'measurements': [{'value': '-5.11', 'spread': '0.597', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '0.448', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)', 'categories': [{'measurements': [{'value': '-5.11', 'spread': '0.595', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '0.448', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, and 12', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks'}, {'id': 'OG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}], 'classes': [{'title': 'On-Treatment Virologic Failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Virologic Relapse', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Posttreatment Week 24', 'description': 'Virologic failure is 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', 'description': 'Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks'}, {'id': 'FG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled study sites in France. The first participant was screened on 26 September 2013. The last study visit occurred on 12 November 2014.', 'preAssignmentDetails': '172 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LDV/SOF', 'description': 'LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks'}, {'id': 'BG001', 'title': 'LDV/SOF + RBV', 'description': 'Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '56', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '56', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitic C Virus (HCV) RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '0.59', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '0.47', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '0.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV Genotype', 'classes': [{'title': 'Genotype 1 (no confirmed subtype)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Genotype 1a', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Genotype 1b', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2013-10-16', 'resultsFirstSubmitDate': '2015-08-27', 'studyFirstSubmitQcDate': '2013-10-16', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-27', 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', '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, \\< 25 IU/mL) 12 weeks following the last dose of study drug.\n\n* 1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.\n* 1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, and 24'}, {'measure': 'Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, and 12'}, {'measure': 'Percentage of Participants With Virologic Failure', 'timeFrame': 'Baseline to Posttreatment Week 24', 'description': 'Virologic failure is 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': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C', 'HCV', 'Cirrhosis'], 'conditions': ['HCV Infection']}, 'referencesModule': {'references': [{'pmid': '25773757', 'type': 'DERIVED', 'citation': 'Bourliere M, Bronowicki JP, de Ledinghen V, Hezode C, Zoulim F, Mathurin P, Tran A, Larrey DG, Ratziu V, Alric L, Hyland RH, Jiang D, Doehle B, Pang PS, Symonds WT, Subramanian GM, McHutchison JG, Marcellin P, Habersetzer F, Guyader D, Grange JD, Loustaud-Ratti V, Serfaty L, Metivier S, Leroy V, Abergel A, Pol S. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015 Apr;15(4):397-404. doi: 10.1016/S1473-3099(15)70050-2. Epub 2015 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data. Approximately 150 participants with genotype 1 HCV infection, who have previously received treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will be randomized to 1 of 2 groups.\n\nGroup 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks\n\nGroup 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks\n\nRandomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b; mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy treatment response (never achieved HCV RNA \\< the lower limit of quantitation (LLOQ), or achieved HCV RNA \\< LLOQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 18 years, with chronic genotype 1 HCV infection\n* HCV RNA ≥ 10,000 IU/mL at screening\n* Prior virological failure after treatment with pegylated interferon (PEG-IFN), RBV and a protease inhibitor following documented prior virology failure after treatment with a PEG-IFN + RBV regimen\n* Evidence of 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* Current or prior history of clinical hepatic decompensation\n* Prior exposure to approved or experimental HCV specific direct-acting antivirals other than a nonstructural protein (NS)3/4A protease inhibitor\n* History of solid organ transplantation, including liver transplant\n* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)\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': 'NCT01965535', 'briefTitle': 'Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-337-0121'}, 'secondaryIdInfos': [{'id': '2013-002296-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LDV/SOF', 'description': 'LDV/SOF FDC tablet plus placebo to match RBV for 24 weeks', 'interventionNames': ['Drug: LDV/SOF', 'Drug: Placebo to match RBV']}, {'type': 'EXPERIMENTAL', 'label': 'LDV/SOF + RBV', 'description': 'Placebo to match SOF/LDV FDC plus placebo to match RBV for 12 weeks, followed by LDV/SOF FDC plus RBV for 12 weeks.', 'interventionNames': ['Drug: LDV/SOF', 'Drug: RBV', 'Drug: Placebo to match LDV/SOF', 'Drug: Placebo to match RBV']}], 'interventions': [{'name': 'LDV/SOF', 'type': 'DRUG', 'otherNames': ['Harvoni®', 'GS-5885/GS-7977'], 'description': 'LDV/SOF (90/400 mg) FDC tablet administered orally once daily', 'armGroupLabels': ['LDV/SOF', 'LDV/SOF + RBV']}, {'name': 'RBV', 'type': 'DRUG', 'description': 'RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing \\< 75 kg; 1200 mg per day for participants weighing ≥ 75 kg)', 'armGroupLabels': ['LDV/SOF + RBV']}, {'name': 'Placebo to match LDV/SOF', 'type': 'DRUG', 'description': 'Placebo to match LDV/SOF administered orally once daily', 'armGroupLabels': ['LDV/SOF + RBV']}, {'name': 'Placebo to match RBV', 'type': 'DRUG', 'description': 'Placebo to match RBV administered orally in a divided daily dose', 'armGroupLabels': ['LDV/SOF', 'LDV/SOF + RBV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '57037', 'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpelier', 'country': 'France'}, {'zip': '54500', 'city': 'Nancy', 'country': 'France', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Robert H 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'}}}}