Hepatitis C Virus
Conditions
Brief summary
The purpose of this study is to assess 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.
Detailed description
* ASV = Asunaprevir (BMS-650032) * DCV = Daclatasvir (BMS-790052) * Peg = Peg-interferon Alfa-2a (PegIFN) * Rib = Ribavirin (RBV)
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females, ≥ 18 years of age * HCV Genotype 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy * 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 * Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease * Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN) * Albumin \< 3.5 g/dL (35 g/L) * Alpha Fetoprotein (AFP) \> 100 ng/mL (\>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded * Absolute neutrophil count (ANC) \< 1.5 x 1000,000,000 cells/L (\< 1.2 x 1000,000,000 cells/L for Black/African-Americans) * Platelets \< 90 x 1000,000,000 cells/L * Hemoglobin \< 12 g/dL for females or \< 13 g/dL for males * Any criteria that would exclude the subject from receiving P/R
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1 | At 12 weeks post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment | Through the end of treatment (maximum up to 24 weeks) plus 7 days |
| Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene | At post-treatment Week 12 |
| Proportion of subjects with HCV RNA undetectable | Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24 |
| Proportion of subjects with HCV RNA < LOQ | Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24) |
| Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects | Post-treatment Week 12 |
Countries
Argentina, Canada, Denmark, France, Germany, Italy, Mexico, Netherlands, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, United States
Outcome results
None listed