Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

Bristol-Myers Squibb (BMS)

Status and phase

Withdrawn

Phase 3

Conditions

Hepatitis C Virus (HCV)

Treatments

Biological: Pegylated Interferon Alfa-2a

Biological: Pegylated Interferon Lambda

Drug: Ribavirin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01447394

2011-003748-31 (EudraCT Number)

AI452-013

Details and patient eligibility

About

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic hepatitis C, Genotype 1 or 4
HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
Naive to prior anti-HCV therapy

Exclusion criteria

Infected with HCV other than Genotype 1 or 4
Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
Evidence of liver disease other than HCV
Active substance abuse
Use of hematologic growth factors within 90 days prior to study randomization
Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria