Hepatitis C Virus Infection
Conditions
Brief summary
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject. The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects
Detailed description
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic HCV-1b infected patient * HCV Ribonucleic acid (RNA) \> 100,000 IU/mL at screening * Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort) * Treatment naive subjects to Interferon (IFN) based therapy * Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up
Exclusion criteria
* Patients who have; * Hepatocellular carcinoma * Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) * Severe or uncontrollable complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort | After 12 weeks of the last dose | * SVR12 = Sustained virologic response at post-treatment Week 12 * LLOQ = Lower Limit of quantitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with rash-related dermatologic events | First 12 weeks of treatment | — |
| Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24 | EOT = End of treatment |
| Proportion of subjects with HCV RNA target not detected in the naive cohort | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24 | eRVR = Extended rapid virologic response |
| Proportion of subjects with hemoglobin < 10g/dL | First 12 weeks of treatment | — |
| Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24 | — |
| Proportion of subjects with HCV RNA target not detected in the relapser cohort | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24 | — |
| On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group | End of treatment (24 weeks) plus 7days | — |
| Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort | At post-treatment Week 12 | — |
Countries
Japan
Outcome results
None listed