An efficacy and safety study of Telaprevir in patients with genotype 1 Hepatitis C infection after liver transplantatio

Conditions: Chronic hepatitis C infection
MedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-004724-35-BE

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

- First time liver transplant recipient whose primary pre-transplant
diagnosis was chronic hepatitis C genotype 1
- More than 6 months to 10 years post-liver transplant - Patient did or did not receive treatment for HCV prior to liver transplantation
- Patient must agree to have a liver graft biopsy within the screening
period with exception made if recent serial biopsy with stable stage of hepatic fibrosis
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient is currently infected or co-infected with HCV of another
genotype than genotype 1
- Patient received treatment for hepatitis C following liver transplantation
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient has human immunodeficiency virus or hepatitis B virus
coinfection
- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)