Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-29 @ 8:22 AM
Study NCT ID:
NCT01581203
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2012-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Singapore']}, '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': 'C549273', 'term': 'daclatasvir'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 748}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2012-04-18', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2012-04-19', 'dispFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive', 'timeFrame': 'At 12 weeks post-treatment'}], 'secondaryOutcomes': [{'measure': 'Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R', 'timeFrame': 'Post-treatment Week 12'}, {'measure': 'On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)', 'timeFrame': 'End of Treatment (up to 48 weeks) plus 7 days'}, {'measure': 'Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects', 'timeFrame': 'Up to first 12 weeks'}, {'measure': 'Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort', 'timeFrame': 'Post-treatment Week 12'}, {'measure': 'Proportion of genotype 1b subjects with HCV RNA undetectable', 'timeFrame': 'At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort', 'description': 'eRVR = Extended rapid virologic response, EOT = End of treatment'}, {'measure': 'Proportion of genotypes 1b subjects with HCV RNA < LOQ', 'timeFrame': 'At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort'}, {'measure': 'Proportion of subjects with anemia', 'timeFrame': 'At 12 weeks post-treatment'}, {'measure': 'Proportion of subjects with rash', 'timeFrame': 'At 12 weeks post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '27009831', 'type': 'DERIVED', 'citation': 'Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28.'}, {'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': '25078304', 'type': 'DERIVED', 'citation': 'Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28.'}], '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 estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \\< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.', 'detailedDescription': 'Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study)\n\nMasking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open\n\nIntervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Males and females, ≥ 18 years of age\n* HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive\n* HCV RNA ≥ 10,000 IU/mL\n* Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)\n* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)\n\nExclusion Criteria:\n\n* Prior treatment of HCV with HCV direct acting antiviral (DAA)\n* Evidence of a medical condition contributing to chronic liver disease other than HCV\n* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy\n* Diagnosed or suspected hepatocellular carcinoma or other malignancies\n* Uncontrolled diabetes or hypertension'}, 'identificationModule': {'nctId': 'NCT01581203', 'acronym': 'Hallmark DUAL', 'briefTitle': 'Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection', 'orgStudyIdInfo': {'id': 'AI447-028'}, 'secondaryIdInfos': [{'id': '2011-005446-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Null or Partial Responder to P/R (ASV + DCV)', 'description': 'Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks\n\nDaclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks', 'interventionNames': ['Drug: Asunaprevir (ASV)', 'Drug: Daclatasvir (DCV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)', 'description': 'Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks\n\nDaclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks', 'interventionNames': ['Drug: Asunaprevir (ASV)', 'Drug: Daclatasvir (DCV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Treatment naive (ASV + DCV)', 'description': '\\[Subjects will receive ASV + DCV for 24 weeks\\] followed by ASV + DCV for 24 weeks in protocol AI444026\\]\n\nSubjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)\n\nAsunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks\n\nDaclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks\n\nPegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks\n\nRibavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks', 'interventionNames': ['Drug: Asunaprevir (ASV)', 'Drug: Daclatasvir (DCV)', 'Drug: Pegylated-interferon alfa 2a (PegIFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week', 'description': 'Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)\n\nAsunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks\n\nDaclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks\n\nPegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks\n\nRibavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks', 'interventionNames': ['Drug: Asunaprevir (ASV)', 'Drug: Daclatasvir (DCV)', 'Drug: Pegylated-interferon alfa 2a (PegIFN)', 'Drug: Ribavirin (RBV)']}], 'interventions': [{'name': 'Asunaprevir (ASV)', 'type': 'DRUG', 'otherNames': ['BMS-650032'], 'armGroupLabels': ['Arm 1: Null or Partial Responder to P/R (ASV + DCV)', 'Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)', 'Arm 3: Treatment naive (ASV + DCV)', 'Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week']}, {'name': 'Daclatasvir (DCV)', 'type': 'DRUG', 'otherNames': ['BMS-790052'], 'armGroupLabels': ['Arm 1: Null or Partial Responder to P/R (ASV + DCV)', 'Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)', 'Arm 3: Treatment naive (ASV + DCV)', 'Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week']}, {'name': 'Pegylated-interferon alfa 2a (PegIFN)', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'armGroupLabels': ['Arm 3: Treatment naive (ASV + DCV)', 'Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Copegus'], 'armGroupLabels': ['Arm 3: Treatment naive (ASV + DCV)', 'Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 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