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

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

Study Classification: Pharmacokinetics/ Pharmacodynamics

Who is eligible to participate?

Inclusion Criteria: - 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% Exclusion Criteria: - 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

Last updated:

10/1/2013

NCT ID:

NCT01309932