Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01428063
First received: September 1, 2011
Last updated: September 22, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition of these drugs can result in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received placebo will be treated with active drugs in this study.


Condition Intervention Phase
Hepatitis C Virus
Drug: Daclatasvir
Drug: Asunaprevir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Efficacy based on the proportion of subjects with Sustained virologic response (SVR)12 [HCV Ribonucleic acid (RNA) < LOQ at Follow-up week 12] for all subjects infected with genotype 1 who are prior non-responders to Peginterferon Alfa-2a/Ribavirin [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy as determined by the proportion of subjects with SVR12 in genotype 2, 3 & 4 prior non-responders to pegIFNα-2a/RBV and treatment naive genotype 1b [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
  • Safety measured by frequency of Serious Adverse Event(s) (SAE)s and discontinuations due to Adverse Events (AEs) [ Time Frame: At End of Treatment (Week 24) & Follow-up Week 4 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who achieve HCV RNA < Limit of quantitation (LOQ) (detectable or undetectable) for each HCV genotype and treatment regimen [ Time Frame: Weeks 1, 2 , 4, 6, 8 & 12, Weeks 4 and 12 [Virologic Response (VR) (4 & 12)], End of Treatment (Week 24) or Follow-up Week 24 (SVR24) ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HCV RNA undetectable for each HCV genotype and treatment regimen [ Time Frame: Week 1, 2, 4, 6, 8 & 12, Weeks 4 and 12 [Extended rapid virologic response (eRVR)], End of Treatment (Week 24), Follow-up week 12 or Follow-up week 24 ] [ Designated as safety issue: No ]
  • Drug-resistant variants associated with virologic failure for each HCV genotype and treatment regimen [ Time Frame: End of Trial (Week 48) ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Daclatasvir+Asunaprevir+Peginterferon alfa-2a+Ribavirin

HCV Genotypes 1 & 4 (prior non-responders to pegIFNα-2a+RBV)

Daclatasvir 60 mg tablet by mouth once daily for 24 weeks

Asunaprevir 100 mg capsule or 200 mg tablet by mouth twice daily for 24 weeks

Peginterferon alfa-2a 180 μg solution subcutaneously weekly for 24 weeks

Ribavirin 1000 or 1200 mg tablet based on weight by mouth daily in two divided doses for 24 weeks

Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: Peginterferon alfa-2a
Other Name: Pegasys®
Drug: Ribavirin
Other Name: Copegus®
Experimental: Arm 2: Daclatasvir + Peginterferon alfa-2a + Ribavirin

HCV Genotypes 2 & 3 (prior non-responders to pegIFNα-2a+RBV)

Daclatasvir 60 mg tablet by mouth once daily for 24 weeks

Peginterferon alfa-2a 180 μg solution subcutaneously, weekly for 24 weeks

Ribavirin 800 mg tablet by mouth daily in two divided doses for 24 weeks

Drug: Daclatasvir
Other Name: BMS-790052
Drug: Peginterferon alfa-2a
Other Name: Pegasys®
Drug: Ribavirin
Other Name: Copegus®
Experimental: Arm 3: Daclatasvir + Asunaprevir

Treatment naive genotype 1b

Daclatasvir 60 mg tablet by mouth once daily for 24 weeks

Asunaprevir 100 mg capsule by mouth twice daily for 24 weeks

Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Experimental: Arm 4: Daclatasvir+Asunaprevir+Peginterferon alfa-2a+Ribavirin

Subjects in the treatment naive cohort meeting pre-specified rescue criteria may have therapeutic rescue instituted with QUAD regimen (QUAD = Daclatasvir + Asunaprevir + Peginterferon alfa-2a + Ribavirin)

Daclatasvir 60 mg tablet by mouth once daily for 24 or 48 weeks

Asunaprevir 100 mg capsule by mouth twice daily for 24 or 48 weeks

Peginterferon alfa-2a 180 μg solution subcutaneously, weekly for 24 or 48 weeks

Ribavirin 1000 or 1200 mg tablets based on weight daily in two divided doses for 24 or 48 weeks

Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: Peginterferon alfa-2a
Other Name: Pegasys®
Drug: Ribavirin
Other Name: Copegus®

Detailed Description:
  • Intervention Model:

    • Parallel: for all subjects entering the trial
    • Cross-over: for genotype 1b subjects rolling over from AI447-028 who require rescue therapy after initial treatment in this study
  • Peginterferon Alfa-2a (pegIFNα-2a)
  • Ribavirin (RBV)
  • Daclatasvir (DCV)
  • Asunaprevir (ASV)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to control arm (Peginterferon α/Ribavirin + Placebo) during the trial
  • HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
  • HCV RNA viral load detectable

Exclusion Criteria:

  • Discontinuation from prior BMS HCV clinical trial due to a Peginterferon/Ribavirin-related event
  • Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or BMS-791325
  • Positive for Hepatitis B infection (Hepatitis B surface antigen (HBsAg)) or Human immunodeficiency virus 1 (HIV-1)/HIV-2 antibody at screening
  • Evidence of medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428063

  Show 107 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01428063     History of Changes
Other Study ID Numbers: AI444-026, 2011-000836-27
Study First Received: September 1, 2011
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Egypt: Institutional Review Board
Egypt: Ministry of Health and Population
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board
Sweden: Regional Ethical Review Board
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014