106
Participants
Start Date
February 28, 2011
Primary Completion Date
September 30, 2012
Study Completion Date
September 30, 2012
TMC435
100-mg capsule taken by mouth once daily for 12 or 24 weeks.
Peginterferon alfa-2a (PegIFNα-2a )
PegIFNα-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.
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
Ichikawa
Kagoshima
Kanazawa
Kawasaki
Kitakyushu
Kumamoto
Kurume
Kyoto
Matsumoto
Musashino
Nishinomiya
Osaka
Ōsaka-sayama
Sakai
Sapporo
Suita
Tokyo
Yokohama
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY