Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

• Status: Completed
• Trial end date: 2015-05-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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

Inclusion Criteria:

• Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects

• Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]

• Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%

• HCV RNA ≥ 100,000 IU/mL

• Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%

• Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)

• Men or women, 18-70 years of age

Exclusion Criteria:

• Chronic liver disease due to causes other than chronic HCV

• Current or past evidence of decompensation

• Conditions that preclude the use of Alfa/RBV/TVR per respective labels

• Diagnosed or suspected hepatocellular carcinoma