457
Participants
Start Date
November 30, 2012
Primary Completion Date
August 31, 2014
Study Completion Date
November 30, 2014
TMC435
TMC435 100 mg or 150 mg capsules taken orally (by mouth) with food once-daily for 12 weeks (Week 12).
Peginterferon-alpha (PegIFNα-2a)
PegIFNα-2a (180 micrograms \[μg\] once weekly) administered as weekly subcutaneous (s.c.) (under the skin) injections of 0.5 mL for 24 or 48 weeks.
Ribavirin (RBV)
Ribavirin 1000 or 1200 mg/day (taken as 100 mg or 200 mg tablets) depending on body weight (If body weight is \< 75 kg the total daily dose of RBV will be 1000 mg, administered as 400 mg intake with food in the morning and 600 mg intake with food in the evening. If body weight is \> or = 75 kg the total daily dose will be 1200 mg, administered as 2 x 600 mg per intake with food, morning and evening) for 24 or 48 weeks.
Placebo
Matching placebo capsules taken orally with food once-daily for 48 weeks.
Beijing
Changchun
Changsha
Chengdu
Chongqing
Guangzhou
Hangzhou
Harbin
Jinan
Lanzhou
Nanjing
Shanghai
Shenyang
Tianjin
Wuhan
Zhengzhou
Busan
Chuncheon, Gangwon-Do
Gyeongsangnam-Do
Incheon
Seoul
Janssen R&D Ireland
INDUSTRY