To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Tablets, Oral, 60 mg, daily, 24 weeks
Tablets, Oral, 1200 mg, daily, 24 weeks
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kawasaki-Shi, Kanagawa, Japan
Local Institution
Minato-Ku, Tokyo, Japan
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
Time frame: 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)
Time frame: Post-treatment Week 12
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
Time frame: 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
Time frame: Week 4
The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL
Time frame: at both Weeks 4 and 12
The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL
Time frame: at follow-up Week 24
Resistant variants associated with clinical failure
Time frame: Weeks 4, 12, end of treatment and post-treatment Week 24
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