An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
- Registration Number
- NCT01051414
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- Subjects chronically infected with HCV Genotype 1
- HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening
Exclusion Criteria
- Subjects with evidence of liver cirrhosis
- Evidence of HCC
- Co-infection with hepatitis B virus, HIV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-790052 + BMS-650032 BMS-650032 - BMS-790052 + BMS-650032 BMS-790052 -
- Primary Outcome Measures
Name Time Method Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs Week 4 Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12) Post-treatment Week 12
- Secondary Outcome Measures
Name Time Method The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL at both Weeks 4 and 12 Resistant variants associated with clinical failure Weeks 4, 12, end of treatment and post-treatment Week 24 The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities Weeks 4, 12, end of treatment and post-treatment Week 24 The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL Week 4 The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL at follow-up Week 24
Trial Locations
- Locations (1)
Local Institution
🇯🇵Minato-Ku, Tokyo, Japan