Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-31 @ 12:13 PM
Study NCT ID:
NCT01030432
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
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': 'C571889', 'term': 'asunaprevir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'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': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2009-12-10', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2009-12-10', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs', 'timeFrame': '12 weeks after first dose'}, {'measure': 'Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA', 'timeFrame': 'Week 4'}, {'measure': 'Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA', 'timeFrame': 'Week 12'}, {'measure': 'Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA', 'timeFrame': 'at follow-up Week 24'}], 'secondaryOutcomes': [{'measure': 'Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)', 'timeFrame': 'at Week 12 (Stage 2 only)'}, {'measure': 'Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only)', 'timeFrame': 'Week 12 (Stage 1 only)'}, {'measure': 'Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12', 'timeFrame': 'follow-up Week 12'}, {'measure': 'Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only)', 'timeFrame': 'follow-up Week 24 (Stage 1 only)'}, {'measure': 'Resistant variants associated with virologic failure', 'timeFrame': '48 weeks after last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '25038486', 'type': 'DERIVED', 'citation': 'Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.'}], '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 identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)\n* Subjects chronically infected with HCV genotype 4 (Phase 2b only)\n* HCV RNA viral load of ≥ 10\\*5\\* IU/mL at screening\n* BMI of 18 - 35 kg/m² at screening\n\nExclusion Criteria:\n\n* Cirrhosis (Phase 2a only)\n* Decompensated cirrhosis (Phase 2b)\n* Co-infection with HBV or HIV\n* Hepatocellular carcinoma\n* Prior treatment with anti-HCV drugs'}, 'identificationModule': {'nctId': 'NCT01030432', 'briefTitle': 'Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': 'AI447-016'}, 'secondaryIdInfos': [{'id': '2009-013652-69', 'type': 'REGISTRY', 'domain': 'EUDRACT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2a: Arm 1', 'interventionNames': ['Drug: BMS-650032', 'Drug: Peginterferon Alfa-2a', 'Drug: Ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2a: Arm 2', 'interventionNames': ['Drug: Placebo', 'Drug: Peginterferon Alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2b: Arm 1', 'interventionNames': ['Drug: BMS-650032', 'Drug: Placebo', 'Drug: Peginterferon Alfa-2a', 'Drug: Ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2b: Arm 2', 'interventionNames': ['Drug: Placebo', 'Drug: Peginterferon Alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Tablets, Oral, 200 mg, Twice Daily, 48 weeks', 'armGroupLabels': ['Phase 2a: Arm 1']}, {'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response', 'armGroupLabels': ['Phase 2b: Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Tablets, Oral, 0 mg, twice daily, 48 weeks', 'armGroupLabels': ['Phase 2a: Arm 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12', 'armGroupLabels': ['Phase 2b: Arm 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, twice daily 24 weeks', 'armGroupLabels': ['Phase 2b: Arm 2']}, {'name': 'Peginterferon Alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks', 'armGroupLabels': ['Phase 2a: Arm 1', 'Phase 2a: Arm 2', 'Phase 2b: Arm 2']}, {'name': 'Peginterferon Alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response', 'armGroupLabels': ['Phase 2b: Arm 1']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus'], 'description': 'Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks', 'armGroupLabels': ['Phase 2a: Arm 1', 'Phase 2a: Arm 2', 'Phase 2b: Arm 2']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Pegasys'], 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