A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

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

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborator: Tibotec Pharmaceutical Limited
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; 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 Hepatitis C Virus (HCV) Ribonucleic Acid (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