Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Chronic Hepatitis C Genotype 1 Subjects With Severe fibrous tissue formation and liver damage.
- Conditions
- Chronic hepatitis C infectionMedDRA version: 16.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-023669-23-HU
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3216
1. Patient must have evidence of chronic Hepatitis C (genotype 1) infection.
2. Patient must have documentation of liver fibrosis assessed by liver biopsy or noninvasive test showing severe fibrosis or cirrhosis
3. Evidence of compensated liver disease
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
1. Patient is infected or co-infected with HCV of another genotype than genotype 1
2. Patient has signs or symptoms of HCC
3. Patient has a history of decompensated liver disease
4. Patient has a co-infection with active hepatitis B or HIV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objectives of this early access program are to provide telaprevir for subjects with genotype 1 chronic hepatitis C with severe fibrosis and compensated cirrhosis who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into an ongoing clinical study of telaprevir, and to collect additional safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV.;Secondary Objective: -;Primary end point(s): In this early access program, all subjects will receive open-label telaprevir in addition to standard of care treatments. Only selected safety and tolerability data will be collected. As such, no formal statistical hypothesis will be tested. ;Timepoint(s) of evaluation of this end point: -
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: -;Secondary end point(s): -