A Phase 2 interventional study of BMS-790052 and BMS-650032 in Hepatitis C Infection, sponsored by Bristol-Myers Squibb. Completed at 4 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 43 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BMS-790052 · Drug: BMS-650032
Tablets, Oral, 60 mg, daily, 24 weeks
Tablets, Oral, 1200 mg, daily, 24 weeks
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
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb