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

Janssen-Cilag International NV74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Interventions

TelaprevirDRUG

Type=exact number, unit=mg, number=375, form=tablet, route=oral. Patients will receive 2 oral tablets (750 mg) every 8 hours for 12 weeks.

Pegylated interferon alfa-2aDRUG

Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.

RibavirinDRUG

Type=exact number, unit=mg, number=200, form=tablet, route=oral. Starting from 600 mg (3 tablets) per day on Day 1. This dose will become higher or lower based on blood results and the investigators opinion (to a goal of 1000 to 1200 mg/day \[5 to 6 tablets\] based on subject weight), twice daily regimen, for 48 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (21)

Unnamed facility

Linz, Austria

Unnamed facility

Vienna, Austria

Unnamed facility

Brussels, Belgium

Outcomes

Primary Outcomes

Number of patients achieving sustained virologic response (SVR) 12 planned

SVR12 planned is defined as having plasma hepatitis C virus (HCV ) ribonucleic acid (RNA) level less than 25 IU/mL 12 weeks after the last planned dose of study medication.

Time frame: Week 60

Secondary Outcomes

Number of patients achieving SVR12 planned(c)

SVR12 planned(c) is defined as having undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study drugs.

Time frame: Week 60

Number of patients achieving SVR24 planned

SVR24 planned is defined as having plasma HCV RNA levels less than 25 IU/mL 24 weeks after the last planned dose of study medication.

Time frame: Week 72

Number of patients achieving SVR24 planned(c)

SVR24 planned(c) is defined as having an undetectable plasma HCV RNA level 24 weeks after the last planned dose of study medication.

Time frame: Week 72

Number of patients having an undetectable HCV RNA level at Week 4 of treatment

Time frame: Week 4

Number of patients having an undetectable HCV RNA level at Week 12 of treatment

Time frame: Week 12

Number of patients having undetectable HCV RNA levels at Week 4 and Week 12 of treatment

Time frame: Week 4 and Week 12

Number of patients having an undetectable HCV RNA level at the actual end of treatment

Time frame: Week 48

Data from ClinicalTrials.gov

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