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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
285
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Tablets, Oral, 0 mg, twice daily, 48 weeks
Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs
Time frame: 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
Time frame: Week 4
Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
Time frame: 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
Time frame: at follow-up Week 24
Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
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Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Tablets, Oral, 0 mg, twice daily 24 weeks
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
University Of Alabama At Birmingham
Birmingham, Alabama, United States
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States
Florida Hospital Transplant Center
Orlando, Florida, United States
Mercy Medical Center
Baltimore, Maryland, United States
The Research Institute
Springfield, Massachusetts, United States
Umass Memorial Medical Center
Worcester, Massachusetts, United States
James J Peters Vamc
The Bronx, New York, United States
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Oregon Health Science Univ
Portland, Oregon, United States
...and 30 more locations
Time frame: follow-up Week 24 (Stage 1 only)
Resistant variants associated with virologic failure
Time frame: 48 weeks after last dose