232
Participants
Start Date
September 30, 2013
Primary Completion Date
August 31, 2015
Study Completion Date
August 31, 2015
TMC435
150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.
Pegylated interferon alfa-2a (PegIFNα-2a)
180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks.
Ribavirin (RBV)
1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is \< 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is \> or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food).
Linz
Vienna
Brussels
Edegem
Clichy
Limoges
Orléans
Saint-Laurent-du-Var
Berlin
Düsseldorf
Frankfurt
Hamburg
Würzburg
Riyadh
Barcelona
Madrid
Valencia
Valme
Glasgow
London
Lead Sponsor
Janssen-Cilag International NV
INDUSTRY