An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation (REPLACE)

This is an interventional treatment trial for Chronic Hepatitis C Virus (HCV) Infection focused on measuring Chronic HCV infection, Genotype 1 chronic HCV, Liver transplantation, Hepatitis C, Hep C, HCV, Telaprevir, Pegylated-Interferon-alfa-2a, Ribavirin Read More

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 during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
• 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

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 with human immunodeficiency virus or hepatitis B virus co-infection
• Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)