A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Hepatitis C, Chronic
Interventions
DRUG

TMC435

100-mg capsule taken by mouth once daily for 12 or 24 weeks.

DRUG

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.

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 (19)

Unknown

Amagasaki

Ichikawa

Kagoshima

Kanazawa

Kawasaki

Kitakyushu

Kumamoto

Kurume

Kyoto

Matsumoto

Musashino

Nishinomiya

Osaka

Ōsaka-sayama

Sakai

Sapporo

Suita

Tokyo

Yokohama

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT01288209 - A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy | Biotech Hunter | Biotech Hunter