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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Virus (HCV) Infection

Treatments: Drug: Ribavirin; Drug: Pegylated interferon alfa-2a; Drug: Telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01571583

2011-004724-35 (EudraCT Number)

VX-950HPC3006 (Other Identifier)

CR018721

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.

Full description

This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Enrollment: 74 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

74 participants in 1 patient group

Telaprevir+Peg-IFN-alfa-2a+Ribavirin

Experimental group

Description:

Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone.

Treatment:

Drug: Ribavirin

Drug: Pegylated interferon alfa-2a

Drug: Telaprevir