An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation
REPLACE
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
3 other identifiers
interventional
74
6 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2012
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 30, 2016
June 1, 2016
2.2 years
December 16, 2011
June 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 60
Secondary Outcomes (17)
Number of patients achieving SVR12 planned(c)
Week 60
Number of patients achieving SVR24 planned
Week 72
Number of patients achieving SVR24 planned(c)
Week 72
Number of patients having an undetectable HCV RNA level at Week 4 of treatment
Week 4
Number of patients having an undetectable HCV RNA level at Week 12 of treatment
Week 12
- +12 more secondary outcomes
Study Arms (1)
Telaprevir+Peg-IFN-alfa-2a+Ribavirin
EXPERIMENTALPatients 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.
Interventions
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.
Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Linz, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Clichy, France
Unknown Facility
Marseille, France
Unknown Facility
Montpellier, France
Unknown Facility
Rennes Cedex N/A, France
Unknown Facility
Villejuif, France
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt A. M., Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV, Belgium Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
April 5, 2012
Study Start
February 1, 2012
Primary Completion
April 1, 2014
Study Completion
July 1, 2014
Last Updated
June 30, 2016
Record last verified: 2016-06