Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT01193361
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2010-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph IIA Study (SOC +/- NS5B)
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': 'C587012', 'term': '8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide'}, {'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': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2010-08-25', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2010-08-31', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)', 'timeFrame': 'Formal analysis at week 4 (and upon occurrence)'}, {'measure': 'Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)', 'timeFrame': 'Formal analysis at week 12 (and upon occurrence)'}, {'measure': 'Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)', 'timeFrame': 'Formal analysis at week 24 post treatment (and upon occurrence)'}, {'measure': 'Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)', 'timeFrame': 'Formal analysis at week 48 post treatment (and upon occurrence)'}, {'measure': 'Antiviral activity, as determined by the proportion subjects with eRVR', 'timeFrame': 'Week 4'}, {'measure': 'Antiviral activity, as determined by the proportion subjects with eRVR', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA', 'timeFrame': 'Week 4'}, {'measure': 'Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA', 'timeFrame': 'Week 12'}, {'measure': 'Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up', 'timeFrame': 'Week 12'}, {'measure': 'Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up', 'timeFrame': 'Week 24'}, {'measure': 'Resistant HCV variants associated with virologic failure', 'timeFrame': 'End of treatment (Week 48) or upon early discontinuation'}]}, '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': 'At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects'}, '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 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening\n* HCV RNA ≥ 10\\*5\\* IU/mL at Screening\n* Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization\n* Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis\n* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ \\[height (m)\\]² at Screening\n\nExclusion Criteria:\n\n* Liver transplant recipients\n* Documented or suspected HCC by imaging or liver biopsy\n* Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)\n* History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)\n* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01193361', 'acronym': 'HEPCAT', 'briefTitle': 'Ph IIA Study (SOC +/- NS5B)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection', 'orgStudyIdInfo': {'id': 'AI443-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin', 'interventionNames': ['Drug: BMS-791325', 'Drug: Peg-interferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin', 'interventionNames': ['Drug: BMS-791325', 'Drug: Peg-interferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin', 'interventionNames': ['Drug: Placebo', 'Drug: Peg-interferon alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'BMS-791325', 'type': 'DRUG', 'description': 'Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response', 'armGroupLabels': ['Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin']}, {'name': 'BMS-791325', 'type': 'DRUG', 'description': 'Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response', 'armGroupLabels': ['Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response', 'armGroupLabels': ['Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin']}, {'name': 'Peg-interferon alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response', 'armGroupLabels': ['Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin', 'Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin', 'Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus'], 'description': 'Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response', 'armGroupLabels': ['Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin', 'Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin', 'Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Digestive Disease Associates, P.A.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Claudia T. Martorell, Md, Llc', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Gastroenterology & Hepatology, Pllc', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Options Health Research, Llc', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'The North Texas Research Institute', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo Medical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Metropolitan Research', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}