Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 70
Updated:	4/21/2016
Start Date:	March 2011
End Date:	September 2014

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

The purpose of this study is to determine if combination therapy with Pegylated Interferon
Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or
BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)
compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48
weeks.

Study Classification: Pharmacokinetics/ Pharmacodynamics

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

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

We found this trial at

sites

Virginia Mason Medical Center

Seattle, Washington 98101

(888) 862-2737