Hepatitis C Virus
Conditions
Brief summary
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
Interventions
DRUGBMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
DRUGPlacebo
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
DRUGRibavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
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 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening * HCV RNA ≥ 10\*5\* IU/mL at Screening * Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization * Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis * Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² at Screening
Exclusion criteria
* Liver transplant recipients * Documented or suspected HCC by imaging or liver biopsy * Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) * History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive) * Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antiviral activity, as determined by the proportion subjects with eRVR | Week 4 |
| Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Formal analysis at week 4 (and upon occurrence) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA | Week 4 |
| Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA | Week 12 |
| Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up | Week 12 |
| Resistant HCV variants associated with virologic failure | End of treatment (Week 48) or upon early discontinuation |
Countries
United States
Outcome results
None listed