183
Participants
Start Date
February 28, 2011
Primary Completion Date
October 31, 2012
Study Completion Date
October 31, 2012
Placebo
Placebo capsule taken by mouth once daily for 12 weeks
TMC435
100-mg capsule taken by mouth once daily for 12 weeks
Peginterferon alfa-2a (pegIFN alfa-2a)
PegIFN alfa-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks for patients randomized to TMC435 and for up to 48 weeks for patients randomized to placebo.
Ribavirin (RBV)
RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is \> 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is \> 60 kg to \<=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is \<=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
Amagasaki
Chiba
Chūō
Hiroshima
Ichikawa
Ikeda
Inashiki
Iruma
Kagoshima
Kanazawa
Kitakyushu
Kumamoto
Kurume
Kyoto
Matsumoto
Musashino
Nagoya
Niigata
Nishinomiya
Ohmura
Osaka
Ōsaka-sayama
Sakai
Sapporo
Sendai
Tokyo
Touon
Yokohama
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY