A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Hepatitis C, Chronic
Interventions
DRUG

TMC435

100 mg capsule taken by mouth once daily for 12 weeks

DRUG

Peginterferon alfa-2b (pegIFN alfa-2b)

PegIFN alfa-2b will be supplied as a vial containing dried and frozen powder with 74,148 or 222 mcg pegIFN alpha-2b attached to 0.7 ml injection water (50, 100 or 150 mcg/0.5mL pegIFN alpha-2b) and will be administered according to the manufacturer's prescribing information as 1.5 mcg/kg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.

DRUG

Ribavirin (RBV)

The dose of RBV given will be based on body weight. If body weight is \> 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 capsules of 200 mg) after breakfast and 600 mg (3 capsules 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 capsules 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 capsule of 200 mg) after breakfast and 400 mg (2 capsules of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.

Trial Locations (11)

Unknown

Amagasaki

Ikeda

Kawasaki

Kumamoto

Niigata

Ohmura

Osaka

Sakai

Sapporo

Suita

Tokyo

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY