Hepatitis C Virus
Conditions
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).
Interventions
DRUGBMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
DRUGPlacebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
DRUGPeginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
DRUGRibavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Cirrhosis (Phase 2a only) * Decompensated cirrhosis (Phase 2b) * Co-infection with HBV or HIV * Hepatocellular carcinoma * Prior treatment with anti-HCV drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 4 |
| 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
| Measure | Time frame |
|---|---|
| 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 rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 | Week 4 |
| Resistant variants associated with virologic failure | 48 weeks after last dose |
| 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) |
| 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) |
Countries
Argentina, France, Germany, Ireland, Italy, Spain, United Kingdom, United States
Outcome results
None listed