Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 1:03 AM
Study NCT ID:
NCT02994056
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2016-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
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': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24', 'description': 'The Safety Analysis Set included all participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'SOF/VEL+ RBV', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 27, 'seriousNumAtRisk': 32, 'deathsNumAffected': 8, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hepatic hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dermo-hypodermitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Mixed hepatocellular cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hepatic hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], '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': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}], 'classes': [{'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '90.7'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '90.3'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '28.4', 'upperLimit': '99.5'}, {'value': '85.7', 'groupId': 'OG003', 'lowerLimit': '42.1', 'upperLimit': '99.6'}]}]}], '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': 'The Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}], 'classes': [{'title': 'Discontinuation of SOF/VEL', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation of RBV', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Week 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '96.5'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '98.6'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '28.4', 'upperLimit': '99.5'}, {'value': '85.7', 'groupId': 'OG003', 'lowerLimit': '42.1', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ 4 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '88.5'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '90.3'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '28.4', 'upperLimit': '99.5'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '96.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HCV RNA < LLOQ While on Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '62.3'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '64.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '96.3'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '100.0'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, and 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': 'Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}], 'classes': [{'title': 'Improved CPT Class', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'Worsened CPT Class', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No Change CPT Class', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Posttreatment Week 24', 'description': 'CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}], 'classes': [{'title': 'Decrease (Improvement)', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Increase (Worsening)', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Posttreatment Week 24', 'description': 'MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute HCV RNA Level Through Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.17', 'spread': '1.187', 'groupId': 'OG000'}, {'value': '5.46', 'spread': '0.537', 'groupId': 'OG001'}, {'value': '6.01', 'spread': '0.502', 'groupId': 'OG002'}, {'value': '4.84', 'spread': '1.058', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.392', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.387', 'groupId': 'OG001'}, {'value': '1.63', 'spread': '0.150', 'groupId': 'OG002'}, {'value': '1.43', 'spread': '0.526', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '0.000', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 2, 4, 8, and 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': 'Change From Baseline in HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}], 'classes': [{'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.72', 'spread': '1.092', 'groupId': 'OG000'}, {'value': '-4.06', 'spread': '0.531', 'groupId': 'OG001'}, {'value': '-4.50', 'spread': '0.366', 'groupId': 'OG002'}, {'value': '-3.41', 'spread': '0.665', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.99', 'spread': '1.238', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '0.520', 'groupId': 'OG001'}, {'value': '-4.88', 'spread': '0.395', 'groupId': 'OG002'}, {'value': '-3.70', 'spread': '1.058', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '1.217', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '0.520', 'groupId': 'OG001'}, {'value': '-4.72', 'spread': '0.445', 'groupId': 'OG002'}, {'value': '-3.70', 'spread': '1.058', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '1.217', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '0.520', 'groupId': 'OG001'}, {'value': '-4.72', 'spread': '0.445', 'groupId': 'OG002'}, {'value': '-3.70', 'spread': '1.058', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 2, 4, 8, and 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': 'Number of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF/VEL+ RBV (GT-1)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG001', 'title': 'SOF/VEL+ RBV (GT-2)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG002', 'title': 'SOF/VEL+ RBV (GT-3)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis'}, {'id': 'OG003', 'title': 'SOF/VEL+ RBV (Total)', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline 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', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF/VEL+ RBV', 'description': 'Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.', 'preAssignmentDetails': '73 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF/VEL+ RBV', 'description': 'SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'IL28B', 'classes': [{'categories': [{'title': 'CC', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'CT', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'TT', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The CC, CT, and TT alleles are different forms of the IL28b gene.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh-Turcotte Class', 'classes': [{'categories': [{'title': 'CPT B [7-9]', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'CPT C [10-15]', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Model for End Stage Liver Disease (MELD) Score Category', 'classes': [{'categories': [{'title': '10-15 MELD Score', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '16-20 MELD Score', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '21-25 MELD Score', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included all participants who took at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-22', 'size': 1181854, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T21:06', 'hasProtocol': True}, {'date': '2018-10-24', 'size': 416039, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-12T21:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2016-12-13', 'resultsFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-17', 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-25', '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 Study Drug (SOF/VEL or RBV) Due to an Adverse Event', 'timeFrame': 'First dose date up to Week 12'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ 4 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants With HCV RNA < LLOQ While on Study Treatment', 'timeFrame': 'Weeks 2, 4, 8, and 12'}, {'measure': 'Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class', 'timeFrame': 'Baseline to Posttreatment Week 24', 'description': 'CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.'}, {'measure': 'Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score', 'timeFrame': 'Baseline to Posttreatment Week 24', 'description': 'MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.'}, {'measure': 'Absolute HCV RNA Level Through Week 12', 'timeFrame': 'Baseline; Weeks 2, 4, 8, and 12'}, {'measure': 'Change From Baseline in HCV RNA', 'timeFrame': 'Baseline; Weeks 2, 4, 8, and 12'}, {'measure': 'Number of Participants With Virologic Failure', 'timeFrame': 'Baseline 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': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* A body mass index (BMI) of ≥ 18 kg/m\\^2\n* Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy\n* Quantifiable HCV RNA at screening\n* Individuals may be non-transplanted or with recurrent HCV post-liver transplant.\n\n * If listed for liver transplant, then the projected date of transplant must be ≥12 weeks after Day1 of treatment\n * If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant\n* CPT score of 10 to 12, inclusive, as determined at screening\n* Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)\n* If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening\n* Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization\n* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n* Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last\n* Lactating females must agree to discontinue nursing before the study drugs are administered\n* Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last\n* Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments\n\nKey Exclusion Criteria:\n\n* Current or prior history of any of the following:\n\n * Clinically significant medical or psychiatric illness or individual is currently under evaluation for a potentially clinically significant illness\n * Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug\n * Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy\n * Significant pulmonary disease, significant cardiac disease or porphyria\n * Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Adults under evaluation for possible malignancy are not eligible\n * Significant drug allergy (such as anaphylaxis or hepatotoxicity)\n* Any history of organ transplant other than liver or kidney\n* Chronic liver disease of a non-HCV etiology\n* Inability to exclude HCC by imaging within 6 months of Day 1\n* Alpha-fetoprotein (AFP) \\> 50 unless negative imaging for hepatic masses within the last 6 months or during screening\n* Active spontaneous bacterial peritonitis at screening\n* Infection requiring systemic antibiotics at the time of screening\n* Evidence of fibrosing cholestatic hepatitis at screening\n* Life threatening serious adverse event (SAE) during screening\n* Active variceal bleeding within 6 months of screening\n* Prior placement of a portosystemic shunt (such as TIPS)\n* ECG with clinically significant abnormalities\n* Laboratory parameters with clinically significant abnormalities\n* Hepatitis B surface antigen positive at screening\n* Infection with human immunodeficiency virus (HIV)\n* Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator\n* Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor\n* Current use of corticosteroids at any dose \\>10 mg of prednisone/day (or equivalent dose of corticosteroid)\n* Use of any prohibited concomitant medications\n* Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening\n* Male with pregnant female partner\n* History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)\n* Contraindications to RBV therapy\n* Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients\n* Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02994056', 'briefTitle': 'Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis', 'orgStudyIdInfo': {'id': 'GS-US-342-4022'}, 'secondaryIdInfos': [{'id': '2016-003066-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOF/VEL+ RBV', 'description': 'SOF/VEL FDC plus RBV for 12 weeks', 'interventionNames': ['Drug: SOF/VEL', 'Drug: RBV']}], 'interventions': [{'name': 'SOF/VEL', 'type': 'DRUG', 'otherNames': ['Epclusa®', 'GS-7977/GS-5816'], 'description': '400/100 mg FDC tablet administered orally once daily', 'armGroupLabels': ['SOF/VEL+ RBV']}, {'name': 'RBV', 'type': 'DRUG', 'description': 'Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.', 'armGroupLabels': ['SOF/VEL+ RBV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Medical Group', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital; Clinical Research Unit', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Digestive Disease Associates, PA', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Southern Therapy and Advanced Research LLC', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'American Research Corporation at Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Liver Disease and Transplant Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington/ Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Hopital Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '18 months after study completion', 'ipdSharing': 'YES', 'description': 'Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}