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

June 29, 2016 updated by: Janssen-Cilag International NV

Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
      • Wien, Austria
  • Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • France
      • Clichy, France
      • Marseille, France
      • Montpellier, France
      • Rennes Cedex N/A, France
      • Villejuif Cedex, France
  • Germany
      • Essen, Germany
      • Frankfurt A. M., Germany
      • Hannover, Germany
      • Leipzig, Germany
      • Münster, Germany
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Valencia, Spain
  • United Kingdom
      • Birmingham, United Kingdom
      • London, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telaprevir+Peg-IFN-alfa-2a+Ribavirin
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.
Drug: Telaprevir
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.
Drug: Pegylated interferon alfa-2a
Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.
Drug: Ribavirin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients achieving sustained virologic response (SVR) 12 planned
Time Frame: Week 60
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.
Week 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients achieving SVR12 planned(c)
Time Frame: Week 60
SVR12 planned(c) is defined as having undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study drugs.
Week 60
Number of patients achieving SVR24 planned
Time Frame: Week 72
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.
Week 72
Number of patients achieving SVR24 planned(c)
Time Frame: Week 72
SVR24 planned(c) is defined as having an undetectable plasma HCV RNA level 24 weeks after the last planned dose of study medication.
Week 72
Number of patients having an undetectable HCV RNA level at Week 4 of treatment
Time Frame: Week 4
Week 4
Number of patients having an undetectable HCV RNA level at Week 12 of treatment
Time Frame: Week 12
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
Week 4 and Week 12
Number of patients having an undetectable HCV RNA level at the actual end of treatment
Time Frame: Week 48
Week 48
Number of patients having an undetectable HCV RNA level at the planned end of treatment
Time Frame: Week 48
Week 48
Number of patients having less than 25 IU/mL at the planned end of treatment
Time Frame: Week 48
Week 48
Number of patients with on-treatment virologic failure
Time Frame: Week 48
Virologic failure is defined as patients who meet a virologic stopping rule and/or meet the definition of viral breakthrough.
Week 48
Number of patients with relapse after undetectable HCV RNA at actual end of treatment
Time Frame: Week 48
Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (less than 25 IU/mL, target not detected) at actual end of treatment.
Week 48
Number of patients with relapse after undetectable HCV RNA at planned end of treatment
Time Frame: Week 48
Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA (less than 25 IU/mL, target not detected) at planned end of treatment.
Week 48
Number of patients with relapse after previous HCV RNA less than 25 IU/mL at planned end of treatment
Time Frame: Week 48
Number of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
Week 48
Number of patients with viral breakthrough
Time Frame: Week 48
Number of patients with viral breakthrough (defined as an increase more than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA more than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
Week 48
Change from baseline in log HCV RNA values
Time Frame: Up to Week 52
Change from baseline in log HCV RNA values at each time point during treatment.
Up to Week 52
Number of patients who have changes in liver graft biopsy histology
Time Frame: Up to Week 72
Up to Week 72
Number of patients with adverse events
Time Frame: Up to Week 72
Up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag International NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR018721
  • VX-950HPC3006 (Other Identifier: Janssen-Cilag International NV, Belgium)
  • 2011-004724-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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