Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT01012895
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2009-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549273', 'term': 'daclatasvir'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2009-11-12', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2009-11-12', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment", 'timeFrame': '12 weeks post treatment'}], 'secondaryOutcomes': [{'measure': 'Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results', 'timeFrame': '12 weeks post-treatment', 'description': 'Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)'}, {'measure': 'Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.', 'timeFrame': 'Day 1 and Day 14'}, {'measure': 'Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.', 'timeFrame': 'Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16'}, {'measure': 'Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.', 'timeFrame': 'Day 1 and Day 14'}, {'measure': 'Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.', 'timeFrame': 'Day 1 and Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '26683763', 'type': 'DERIVED', 'citation': 'Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.'}, {'pmid': '23504694', 'type': 'DERIVED', 'citation': 'McPhee F, Hernandez D, Yu F, Ueland J, Monikowski A, Carifa A, Falk P, Wang C, Fridell R, Eley T, Zhou N, Gardiner D. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013 Sep;58(3):902-11. doi: 10.1002/hep.26388. Epub 2013 Jul 16.'}, {'pmid': '22256805', 'type': 'DERIVED', 'citation': 'Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012 Jan 19;366(3):216-24. doi: 10.1056/NEJMoa1104430.'}], '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 determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects ages 18 to 70 years\n* HCV-Infected Genotype 1 Null responders to current standard of care\n* Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.\n\nExclusion Criteria:\n\n* Evidence of a medical condition associate with chronic liver disease other than HCV\n* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis\n* History of Cancer within 5 years of enrollment\n* History of gastrointestinal disease or surgical procedure (except Cholecystectomy)\n* History of clinically significant cardiac disease\n* History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency\n* Documented cirrhosis within 12 months prior to dosing\n* Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT01012895', 'briefTitle': 'Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1', 'orgStudyIdInfo': {'id': 'AI447-011'}, 'secondaryIdInfos': [{'id': '2010-024637-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Sentinel A', 'description': 'BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Sentinel B', 'description': 'BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032', 'Drug: Pegylated-interferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Expansion A1', 'description': 'BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Expansion A2', 'description': 'BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: Expansion B1', 'description': 'BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032', 'Drug: Pegylated-interferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6: Expansion B2', 'description': 'BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032', 'Drug: Pegylated-interferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7: Expansion B3', 'description': 'BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin', 'interventionNames': ['Drug: BMS-790052', 'Drug: BMS-650032', 'Drug: Ribavirin']}], 'interventions': [{'name': 'BMS-790052', 'type': 'DRUG', 'description': 'Tablets, Oral, 60 mg, once daily, 24 weeks', 'armGroupLabels': ['Arm 1: Sentinel A', 'Arm 2: Sentinel B', 'Arm 3: Expansion A1', 'Arm 4: Expansion A2', 'Arm 5: Expansion B1', 'Arm 6: Expansion B2', 'Arm 7: Expansion B3']}, {'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Tablets, Oral, 600 mg, twice daily, 24 weeks', 'armGroupLabels': ['Arm 1: Sentinel A', 'Arm 2: Sentinel B']}, {'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Tablets, Oral, 200mg, twice daily, 24 weeks', 'armGroupLabels': ['Arm 3: Expansion A1', 'Arm 5: Expansion B1', 'Arm 7: Expansion B3']}, {'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Tablets, Oral, 200 mg, once daily, 24 weeks', 'armGroupLabels': ['Arm 4: Expansion A2', 'Arm 6: Expansion B2']}, {'name': 'Pegylated-interferon alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Syringe, Subcutaneous Injection, 180 µg, once weekly', 'armGroupLabels': ['Arm 2: Sentinel B', 'Arm 5: Expansion B1', 'Arm 6: Expansion B2']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus'], 'description': 'Tablets, Oral\n\nFor subjects weighing \\< 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg\n\nTwice daily (\\< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks', 'armGroupLabels': ['Arm 2: Sentinel B', 'Arm 5: Expansion B1', 'Arm 6: Expansion B2', 'Arm 7: Expansion B3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Liver Centers', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'San Jose Gastroenterology', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University Of Colorado Denver & Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University Of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '28677', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Center For Liver Disease', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Clinical Research Institute, Llc', '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}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Local Institution', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}