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

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00758043

Run by

Vertex Pharmaceuticals Incorporated

People needed

540

Starts

2008-10-01

Expected to finish

2010-07-01

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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