Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis

Completed · 2011 until 2013

Clinical Studies
Multicentric, KSSG as main centre
Start Date
End Date
Study Design
early access programm
Brief description/objective

A multicenter, multinational, open-label, non-comparative early access program designed to provide telaprevir to subjects who are expected to benefit from telaprevir-based therapy and to collect additional safety and tolerability data on telaprevir treatment in combination with peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV). Eligible subjects include men and women, between 18 and 70 years of age, inclusive, with hepatitis C virus (HCV) infection genotype 1, a quantifiable serum HCV RNA, documentation of liver fibrosis, and compensated liver disease (Child Pugh Grade A). Subjects will be excluded if they are eligible for enrollment into an ongoing clinical study of telaprevir.
All eligible subjects will receive telaprevir 750 mg every 8 hours during 12 weeks in combination with standard-of-care (Peg-IFN-alfa/RBV). Subjects will subsequently be treated with Peg-IFN-alfa/RBV for either an additional 12 or 36 weeks based on virologic response to treatment and/or by type of subject (treatment naïve or prior treatment relapsers, or previously treated with prior partial or prior null response, or who had viral breakthrough; and Metavir/Ishak score). Virologic response will be measured throughout the study by plasma HCV RNA levels.