A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Placebo

Placebo capsule taken by mouth once daily for 12 weeks

DRUG

TMC435

100-mg capsule taken by mouth once daily for 12 weeks

DRUG

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.

DRUG

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.

Trial Locations (28)

Unknown

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

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY