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

NCT ID: NCT01571583

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-07-31

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.

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.

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

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-2a

Intervention Type: DRUG

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

Ribavirin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV, Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Linz, , Austria

Vienna, , Austria

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Clichy, , France

Marseille, , France

Montpellier, , France

Rennes Cedex N/A, , France

Villejuif, , France

Essen, , Germany

Frankfurt A. M., , Germany

Hanover, , Germany

Leipzig, , Germany

Münster, , Germany

Barcelona, , Spain

Madrid, , Spain

Valencia, , Spain

Birmingham, , United Kingdom

London, , United Kingdom

Countries

Austria; Belgium; France; Germany; Spain; United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3339&filename=20150616_VX-950HPC3006(CR018721)_PRF.pdf

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(18137).

Other Identifiers

VX-950HPC3006

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004724-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR018721

Identifier Type: -

Identifier Source: org_study_id