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: 0
• Participant gender: All

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

Criteria

Inclusion Criteria:

• have evidence of hepatitis C virus infection genotype 1 (by molecular assay); - have quantifiable plasma hepatitis C viral RNA levels; - have documented liver fibrosis as assessed by liver biopsy or a non-invasive test showing severe fibrosis or cirrhosis (for subjects with severe fibrosis, the diagnostic test should have been performed within the past 18 months); - have compensated liver disease (Child-Pugh Grade A clinical classification); - have access to hepatitis C treatment (peginterferon-alfa/ribavarin)

Exclusion Criteria:

• eligible for enrollment into an ongoing clinical study of telaprevir; - infected or co-infected with hepatitis C virus of a genotype other than genotype 1 and/or co-infected with HIV; - contraindication to the administration of peginterferon-alfa or ribavarin, or medical history or laboratory values that preclude treatment with peginterferon-alfa or ribavarin according to the respective local prescribing information; - history of having previously received an investigational treatment with hepatitis C viral protease or polymerase inhibitors (a class of drugs like telaprevir); - signs or symptoms of hepatocellular carcinoma (tests for serum alpha-fetoprotein and ultrasonography should have been done a maximum of 4 months before screening to screen for hepetocellular carcinoma)