163
Participants
Start Date
April 30, 2012
Primary Completion Date
March 31, 2014
Study Completion Date
June 30, 2014
Telaprevir
Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.
Ribavirin
Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.
Pegylated-Interferon-alfa-2a
Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.
Cairns
Darlinghurst
Melbourne
Campinas
Rio de Janeiro
Santo André
São Paulo
Le Kremlin-Bicêtre
Marseille
Nice
Paris
Bydgoszcz
Mysłowice
Warsaw
Krasnodar
Perm
Saint Petersburg
Smolensk
Voronezh
Alicante
Badalona
Córdoba
Donostia / San Sebastian
Elche
Madrid
Seville
Valencia
Stockholm
Birmingham
Glasgow
London
Lead Sponsor
Janssen-Cilag International NV
INDUSTRY