Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
- Conditions
- Hepatitis C Virus
- Interventions
- Registration Number
- NCT01030432
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
- Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
- Subjects chronically infected with HCV genotype 4 (Phase 2b only)
- HCV RNA viral load of ≥ 10*5* IU/mL at screening
- BMI of 18 - 35 kg/m² at screening
- Cirrhosis (Phase 2a only)
- Decompensated cirrhosis (Phase 2b)
- Co-infection with HBV or HIV
- Hepatocellular carcinoma
- Prior treatment with anti-HCV drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2a: Arm 1 BMS-650032 - Phase 2a: Arm 2 Placebo - Phase 2b: Arm 1 BMS-650032 - Phase 2b: Arm 1 Placebo - Phase 2b: Arm 2 Placebo - Phase 2a: Arm 1 Peginterferon Alfa-2a - Phase 2a: Arm 1 Ribavirin - Phase 2a: Arm 2 Peginterferon Alfa-2a - Phase 2a: Arm 2 Ribavirin - Phase 2b: Arm 1 Peginterferon Alfa-2a - Phase 2b: Arm 1 Ribavirin - Phase 2b: Arm 2 Peginterferon Alfa-2a - Phase 2b: Arm 2 Ribavirin -
- Primary Outcome Measures
Name Time Method Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs 12 weeks after first dose Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA Week 12 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 at follow-up Week 24
- Secondary Outcome Measures
Name Time Method Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 Week 4 Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only) at Week 12 (Stage 2 only) 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) Week 12 (Stage 1 only) Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 follow-up Week 12 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) follow-up Week 24 (Stage 1 only) Resistant variants associated with virologic failure 48 weeks after last dose
Trial Locations
- Locations (16)
Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Hospital Of The University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Alabama Liver & Digestive Specialists (Alds)
🇺🇸Montgomery, Alabama, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
James J Peters Vamc
🇺🇸Bronx, New York, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Dean Clinic
🇺🇸Madison, Wisconsin, United States
Local Institution
🇬🇧Glasgow, Lanarkshire, United Kingdom
Local Instituition
🇫🇷Montpellier Cedex 5, France
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Oregon Health Science Univ
🇺🇸Portland, Oregon, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
Florida Hospital Transplant Center
🇺🇸Orlando, Florida, United States
University Of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States