Overview

Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.
Details
Lead Sponsor:
Janssen-Cilag International NV
Treatments:
Ribavirin