A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Hepatitis C, Chronic
Interventions
DRUG

TMC435

100-mg capsule once daily for 12 weeks

DRUG

Pegylated interferon (pegIFN alpha-2a)

180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48).

DRUG

Ribavirin (RBV)

200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).

Trial Locations (10)

Unknown

Hiroshima

Ichikawa

Kagoshima

Matsumoto

Musashino

Ohmura

Osaka

Sapporo

Suita

Touon

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY