Hepatitis C Virus
Conditions
Brief summary
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
Detailed description
Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study) Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group
Interventions
DRUGAsunaprevir (ASV)
DRUGPegylated-interferon alfa 2a (PegIFN)
DRUGRibavirin (RBV)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Males and females, ≥ 18 years of age * HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive * HCV RNA ≥ 10,000 IU/mL * Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg) * Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
Exclusion criteria
* Prior treatment of HCV with HCV direct acting antiviral (DAA) * Evidence of a medical condition contributing to chronic liver disease other than HCV * Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * Diagnosed or suspected hepatocellular carcinoma or other malignancies * Uncontrolled diabetes or hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive | At 12 weeks post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) | End of Treatment (up to 48 weeks) plus 7 days | — |
| Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects | Up to first 12 weeks | — |
| Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort | Post-treatment Week 12 | — |
| Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R | Post-treatment Week 12 | — |
| Proportion of genotypes 1b subjects with HCV RNA < LOQ | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort | — |
| Proportion of subjects with anemia | At 12 weeks post-treatment | — |
| Proportion of subjects with rash | At 12 weeks post-treatment | — |
| Proportion of genotype 1b subjects with HCV RNA undetectable | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort | eRVR = Extended rapid virologic response, EOT = End of treatment |
Countries
Argentina, Australia, Austria, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed