CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 49 enrolled
Drug / intervention
TMC435 +2 moredrug
Likely dose
Pegylated interferon (pegIFN alpha-2a) 180 mcgfrom 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/NCT01290731
NCT01290731Phase 3Completed
CompareCT.gov

A Phase III, Open-label Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Genotype 1, Hepatitis C-infected Subjects Who Relapsed After Previous IFN-based Therapy

Janssen Pharmaceutical K.K.·interventional·Posted Feb 7, 2011·Updated Feb 4, 2014

In Brief

A Phase 3 clinical trial evaluating TMC435, Pegylated interferon (pegIFN alpha-2a), and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 49 participants across 10 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in Japan.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.4 years ago

Interventions

TMC435drug

100-mg capsule once daily for 12 weeks

Pegylated interferon (pegIFN alpha-2a)drug

180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48).

Ribavirin (RBV)drug

200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).