A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Hepatitis C, Chronic
Interventions
DRUG

TMC435

One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks

DRUG

PegIFNα-2a

One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.

DRUG

RBV

300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.

Trial Locations (19)

Unknown

Amagasaki

Hiroshima

Kagoshima

Kawasaki

Kitakyushu

Kurume

Kyoto

Matsumoto

Musashino

Nishinomiya

Ohmura

Osaka

Ōsaka-sayama

Sakai

Sapporo

Suita

Tokyo

Touon

Yokohama

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT00996476 - A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients | Biotech Hunter | Biotech Hunter