74
Participants
Start Date
February 29, 2012
Primary Completion Date
April 30, 2014
Study Completion Date
July 31, 2014
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.
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.
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.
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
Lead Sponsor
Janssen-Cilag International NV
INDUSTRY