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

A Phase II, Randomized, Open-label Study in Japan to Investigate the Efficacy, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment naïve, Genotype 1, Chronic Hepatitis C Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-10-16
• Last updated: 2014-04-17
• Results posted: 2014-04-17

Locations

19 sites across 1 country: Japan