Hepatitis C Infection
Conditions
Brief summary
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
Interventions
DRUGBMS-790052
Tablets, Oral, 60 mg, daily, 24 weeks
DRUGBMS-650032
Tablets, Oral, 1200 mg, daily, 24 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL | at both Weeks 4 and 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 | Weeks 4, 12, end of treatment and post-treatment Week 24 |
| Resistant variants associated with clinical failure | Weeks 4, 12, end of treatment and post-treatment Week 24 |
| The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL | at follow-up Week 24 |
| The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL | Week 4 |
Countries
Japan
Outcome results
None listed