CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 771 enrolled
Drug / intervention
TMC435 +1 moredrug
Likely dose
TVR 150 mgfrom 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/NCT01485991
NCT01485991Phase 3Completed
CompareCT.gov

Phase III in Partial and Null Responders

Janssen R&D Ireland·interventional·Posted Dec 6, 2011·Updated Apr 26, 2016

In Brief

A Phase 3 clinical trial evaluating TMC435 and TVR for Hepatitis C. Completed, enrolled 771 participants across 137 sites in 24 countries.

Detailed Summary

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Norway, Poland, Portugal, Puerto Rico, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2011
Enrollment StartFeb 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.6 years ago

Interventions

TMC435drug

TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.

TVRdrug

TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks