An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

457

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

November 30, 2014

Conditions
Hepatitis C, Chronic
Interventions
DRUG

TMC435

TMC435 100 mg or 150 mg capsules taken orally (by mouth) with food once-daily for 12 weeks (Week 12).

DRUG

Peginterferon-alpha (PegIFNα-2a)

PegIFNα-2a (180 micrograms \[μg\] once weekly) administered as weekly subcutaneous (s.c.) (under the skin) injections of 0.5 mL for 24 or 48 weeks.

DRUG

Ribavirin (RBV)

Ribavirin 1000 or 1200 mg/day (taken as 100 mg or 200 mg tablets) depending on body weight (If body weight is \< 75 kg the total daily dose of RBV will be 1000 mg, administered as 400 mg intake with food in the morning and 600 mg intake with food in the evening. If body weight is \> or = 75 kg the total daily dose will be 1200 mg, administered as 2 x 600 mg per intake with food, morning and evening) for 24 or 48 weeks.

DRUG

Placebo

Matching placebo capsules taken orally with food once-daily for 48 weeks.

Trial Locations (21)

Unknown

Beijing

Changchun

Changsha

Chengdu

Chongqing

Guangzhou

Hangzhou

Harbin

Jinan

Lanzhou

Nanjing

Shanghai

Shenyang

Tianjin

Wuhan

Zhengzhou

Busan

Chuncheon, Gangwon-Do

Gyeongsangnam-Do

Incheon

Seoul

All Listed Sponsors
lead

Janssen R&D Ireland

INDUSTRY

NCT01725529 - An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients | Biotech Hunter | Biotech Hunter