A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects
Trial status: Open for Enrollment
Why is this study being done?
Study Classification: Pharmacokinetics/ Pharmacodynamics
Who is eligible to participate?
- Chronic Hepatitis C, Genotype 1
- HCV RNA >100,000 IU/mL at screening;
- Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
- Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
- Any evidence of liver disease other than HCV;
- Co-infection with HIV;
- Diagnosed or suspected hepatocellular carcinoma;
- Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin