Status:
NO_LONGER_AVAILABLE
Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Brief 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-base...
Detailed Description
This is a multicenter, multinational, open-label, non-comparative early access program designed to provide telaprevir to patients infected with hepatitis C virus genotype 1, who have a documented diag...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01508286
Last Update
July 24 2015
Active Locations (128)
Enter a location and click search to find clinical trials sorted by distance.
1
Adelaide, Australia
2
Bedford, Australia
3
Box Hill, Australia
4
Camperdown, Australia