Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT01629732
Status:
WITHDRAWN
Last Update Posted:
2014-05-09
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C549273', 'term': 'daclatasvir'}, {'id': 'C553340', 'term': 'BMS-986094'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, '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'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)', 'timeFrame': 'Follow up Week 4', 'description': '* SVR = Sustained virologic response\n* HCV = Hepatitis C virus\n* RNA = Ribonucleic acid\n* LOQ = Limit of quantitation'}], 'secondaryOutcomes': [{'measure': 'Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b)', 'timeFrame': 'Follow up Week 4 (SVR4)'}, {'measure': 'Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7)', 'timeFrame': 'Follow up Week 4 (SVR4)'}, {'measure': 'Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment', 'timeFrame': 'Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms)'}, {'measure': 'Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)', 'timeFrame': 'Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)'}, {'measure': 'Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable', 'timeFrame': 'Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)'}, {'measure': 'Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities', 'timeFrame': 'Up to post treatment Week 36'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, ≥ 18 years of age\n* Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4\n* HCV RNA viral load ≥ 10,000 IU/mL\n* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)\n* Body Mass Index (BMI) of 18 to 35 kg/m2\n* Seronegative for Hepatitis C virus (HIV) and Hepatitis B\n\nExclusion Criteria:\n\n* Evidence of decompensated liver disease\n* Evidence of medical condition contributing to chronic liver disease other than HCV'}, 'identificationModule': {'nctId': 'NCT01629732', 'briefTitle': 'Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'AI472-007'}, 'secondaryIdInfos': [{'id': '2012-002519-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo', 'description': 'Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)\n\nRe-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094', 'Drug: Placebo for BMS-986094']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Daclasasvir + BMS-986094 (200 mg)', 'description': 'Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)\n\nRe-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin', 'description': 'Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)\n\nRe-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094', 'Drug: Ribavirin', 'Drug: Placebo for BMS-986094']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin', 'description': 'Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)\n\nRe-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: Daclasasvir + BMS-986094 (200 mg)', 'description': 'Genotype 1 PI-failure subjects', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6: Daclasasvir + BMS-986094 (200 mg)', 'description': 'Genotype 4 naive subjects', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7: Daclasasvir + BMS-986094 (200 mg)', 'description': 'Genotype 2/3 NR/relapse Subjects', 'interventionNames': ['Drug: Daclatasvir', 'Drug: BMS-986094']}], 'interventions': [{'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['BMS-790052 (DCV)'], 'description': 'Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks', 'armGroupLabels': ['Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo', 'Arm 2: Daclasasvir + BMS-986094 (200 mg)', 'Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin', 'Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin']}, {'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['BMS-790052 (DCV)'], 'description': 'Film coated tablet, Oral, 60 mg, Once daily, 24 weeks', 'armGroupLabels': ['Arm 5: Daclasasvir + BMS-986094 (200 mg)', 'Arm 6: Daclasasvir + BMS-986094 (200 mg)', 'Arm 7: Daclasasvir + BMS-986094 (200 mg)']}, {'name': 'BMS-986094', 'type': 'DRUG', 'description': 'Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks', 'armGroupLabels': ['Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo', 'Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin']}, {'name': 'BMS-986094', 'type': 'DRUG', 'description': 'Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks', 'armGroupLabels': ['Arm 2: Daclasasvir + BMS-986094 (200 mg)', 'Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin']}, {'name': 'BMS-986094', 'type': 'DRUG', 'description': 'Capsule, Oral, 200 mg, Once daily, 24 Weeks', 'armGroupLabels': ['Arm 5: Daclasasvir + BMS-986094 (200 mg)', 'Arm 6: Daclasasvir + BMS-986094 (200 mg)', 'Arm 7: Daclasasvir + BMS-986094 (200 mg)']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus®'], 'description': 'Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks', 'armGroupLabels': ['Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin', 'Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin']}, {'name': 'Placebo for BMS-986094', 'type': 'DRUG', 'description': 'Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks', 'armGroupLabels': ['Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo', 'Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}