Kantonsspital St.Gallen

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

Jan Borovicka, Mikael Sawatzki, Patrizia Künzler Heule & David Semela

abstract 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.
type of project clinical studies
status completed
start of project 2011
end of project 2013
study design early access programm
responsible person Dr. David Semela