A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

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

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborator: Tibotec Pharmaceutical Limited
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C

• Male and female subjects, 18 to 70 years of age, inclusive

• Genotype 1, chronic hepatitis C with detectable HCV RNA.

• Screening laboratory values, tests, and physical exam within acceptable ranges

• Able and willing to follow contraception requirements

• Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Exclusion Criteria:

• Subject has any contraindications to Pegasys® or Copegus® therapy

• Evidence of hepatic decompensation in cirrhotic subjects

• History of organ transplant

• History of, or any current medical condition which could impact the safety of the subject in participation in the study