CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
TMC435 +2 moredrug
Likely dose
PegIFNα-2a 180 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00996476
NCT00996476Phase 2Completed
CompareCT.gov

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

Janssen Pharmaceutical K.K.·interventional·Posted Oct 16, 2009·Updated Apr 17, 2014

In Brief

A Phase 2 clinical trial evaluating TMC435, PegIFNα-2a, and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 92 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2009
Enrollment StartJul 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.7 years ago

Interventions

TMC435drug

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

PegIFNα-2adrug

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

RBVdrug

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