A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Hepatitis C, ChronicInfection
Interventions
DRUG

TMC435

150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.

DRUG

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.

DRUG

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).

Trial Locations (20)

Unknown

Linz

Vienna

Brussels

Edegem

Clichy

Limoges

Orléans

Saint-Laurent-du-Var

Berlin

Düsseldorf

Frankfurt

Hamburg

Würzburg

Riyadh

Barcelona

Madrid

Valencia

Valme

Glasgow

London

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection | Biotech Hunter | Biotech Hunter