Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-25 @ 7:39 AM
Study NCT ID:
NCT01896193
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks plus 30 days', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'SOF+RBV 16 Weeks', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks', 'otherNumAtRisk': 62, 'otherNumAffected': 16, 'seriousNumAtRisk': 62, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SOF+RBV 24 Weeks', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks', 'otherNumAtRisk': 65, 'otherNumAffected': 21, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+RBV 16 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)'}, {'id': 'OG001', 'title': 'SOF+RBV 24 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)'}, {'id': 'OG002', 'title': 'SOF+RBV 16 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)'}, {'id': 'OG003', 'title': 'SOF+RBV 24 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}, {'value': '86.7', 'groupId': 'OG002'}, {'value': '90.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug'}, {'type': 'PRIMARY', 'title': 'Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+RBV 16 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)'}, {'id': 'OG001', 'title': 'SOF+RBV 24 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)'}, {'id': 'OG002', 'title': 'SOF+RBV 16 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)'}, {'id': 'OG003', 'title': 'SOF+RBV 24 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+RBV 16 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)'}, {'id': 'OG001', 'title': 'SOF+RBV 24 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)'}, {'id': 'OG002', 'title': 'SOF+RBV 16 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)'}, {'id': 'OG003', 'title': 'SOF+RBV 24 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}, {'value': '90.3', 'groupId': 'OG003'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}, {'value': '86.7', 'groupId': 'OG002'}, {'value': '90.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR 24 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 Experiencing On-treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+RBV 16 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)'}, {'id': 'OG001', 'title': 'SOF+RBV 24 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)'}, {'id': 'OG002', 'title': 'SOF+RBV 16 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)'}, {'id': 'OG003', 'title': 'SOF+RBV 24 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'On-treatment virologic failure was defined as\n\n* Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n* Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n* Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Virologic Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+RBV 16 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)'}, {'id': 'OG001', 'title': 'SOF+RBV 24 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)'}, {'id': 'OG002', 'title': 'SOF+RBV 16 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)'}, {'id': 'OG003', 'title': 'SOF+RBV 24 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '13.3', 'groupId': 'OG002'}, {'value': '9.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 12', 'description': 'Virologic relapse was defined as 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': 'SOF+RBV 16 Weeks', 'description': 'Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks'}, {'id': 'FG001', 'title': 'SOF+RBV 24 Weeks', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at a total of 16 study sites in Russia. The first participant was screened on 06 June 2013. The last study visit occurred on 27 July 2014.', 'preAssignmentDetails': '139 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF+RBV 16 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)'}, {'id': 'BG001', 'title': 'SOF+RBV 24 Weeks, GT1', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)'}, {'id': 'BG002', 'title': 'SOF+RBV 16 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)'}, {'id': 'BG003', 'title': 'SOF+RBV 24 Weeks, GT3', 'description': 'SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '42', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '38', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '40', 'spread': '9.6', 'groupId': 'BG003'}, {'value': '40', 'spread': '10.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cirrhosis Status', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IL28b Status', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '0.60', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '0.81', 'groupId': 'BG002'}, {'value': '6.2', 'spread': '0.77', 'groupId': 'BG003'}, {'value': '6.2', 'spread': '0.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'title': '< 800,000 IU/mL', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}, {'title': '≥ 800,000 IU/mL', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2013-07-02', 'resultsFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2013-07-08', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-07', 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) at 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) at 12 weeks after stopping study treatment.'}, {'measure': 'Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)', 'timeFrame': 'Up to 24 weeks', 'description': 'The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR 24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.'}, {'measure': 'Percentage of Participants Experiencing On-treatment Virologic Failure', 'timeFrame': 'Up to 24 weeks', 'description': 'On-treatment virologic failure was defined as\n\n* Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n* Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n* Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)'}, {'measure': 'Percentage of Participants Experiencing Virologic Relapse', 'timeFrame': 'Up to Posttreatment Week 12', 'description': 'Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '27376706', 'type': 'DERIVED', 'citation': 'Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed chronic genotype 1 or 3 HCV infection\n* HCV treatment-naive\n* Individuals will have cirrhosis status assessment; liver biopsy may be required.\n* Screening laboratory values within predefined 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* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)\n* Contraindication to ribavirin therapy\n* Excessive alcohol ingestion as defined by protocol\n* History of solid organ transplantation\n* Current or prior history of clinical hepatic decompensation\n* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT01896193', 'briefTitle': 'Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.', 'orgStudyIdInfo': {'id': 'GS-US-334-0119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOF+RBV 16 Weeks', 'description': 'SOF+RBV for 16 weeks', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+RBV 24 Weeks', 'description': 'SOF+RBV for 24 weeks', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}], 'interventions': [{'name': 'SOF', 'type': 'DRUG', 'otherNames': ['Sovaldi®', 'PSI-7977', 'GS-7977'], 'description': 'Sofosbuvir (SOF) 400 mg tablet administered orally once daily', 'armGroupLabels': ['SOF+RBV 16 Weeks', 'SOF+RBV 24 Weeks']}, {'name': 'RBV', 'type': 'DRUG', 'description': 'Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)', 'armGroupLabels': ['SOF+RBV 16 Weeks', 'SOF+RBV 24 Weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Central Clinical Hospital of the Russian Academy of Sciences', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital 24', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinical Diagnostics and Research Center of Federal Bedgetary Institution', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Infectious Clinical Hospital No. 1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Institute of Nutrition of Academy of Sciences', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Institution of Healthcare of Sverdlovsk Region', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Institution of High Professional Education First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Institution of Tumen Region', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Stavropol State Medical University of Ministry of Healthcare', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Medical Military Academy n.a. S.M. Kirov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Medical Company Hepatolog', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'overallOfficials': [{'name': 'Kathryn Kersey, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}