Clinical trial NCT00996476
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C Hepatitis C virus Interferon Alfa-2a Ribavirin Viral RNA
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2009-07-01; Completion date: 2011-01-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C infection.

Detailed description:
This is a Phase 2, randomized (The study medication is assigned by chance.), 5-arm, open label (All people know the identity of the intervention.), multicentre (study conducted at multiple sites) study. Approximately, 84 participants will be randomized to 5 different arms in a 2:2:1:1:1 ratio. In treatment arms 1 and 2, participants will receive 12 weeks of triple therapy (use of 3 medications) with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin followed by 12 weeks of treatment with Peginterferon Alfa-2a and Ribavirin. In treatment arms 3 and 4, participants will receive 24 weeks of triple therapy with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin. In treatment arm 5 (control group), participants will receive Peginterferon Alfa-2a and Ribavirin for 48 weeks. This study will consist a screening phase of upto 6 weeks, treatment phase of upto 48 weeks and a post treatment follow-up period of 24 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and cardiovascular safety.

Arms: arm 1: Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. arm 2: Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. arm 3: Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48. arm 4: Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48. arm 5: Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
Interventions: intervention 1: TMC435 intervention 2: PegIFNα-2a intervention 3: RBV
Intervention descriptions: intervention 1: One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks intervention 2: One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks. intervention 3: 300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.

Protocol documents: