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

PHASE3CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

July 31, 2014

Conditions
Chronic Hepatitis C Virus (HCV) Infection
Interventions
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.

Trial Locations (21)

Unknown

Linz

Vienna

Brussels

Ghent

Leuven

Liège

Clichy

Marseille

Montpellier

Rennes Cedex N/A

Villejuif

Essen

Frankfurt A. M.

Hanover

Leipzig

Münster

Barcelona

Madrid

Valencia

Birmingham

London

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY