CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 395 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Placebo 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/NCT01289782
NCT01289782Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Treatment-naïve, Genotype 1 Hepatitis Cinfected Subjects

Janssen R&D Ireland·interventional·Posted Feb 4, 2011·Updated Jun 4, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, TMC435, and 2 other interventions for Hepatitis C. Completed, enrolled 395 participants across 62 sites in 12 countries.

Detailed Summary

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, Canada, Germany, Mexico, New Zealand, Puerto Rico, Romania, Russia, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.4 years ago

Interventions

Placebodrug

150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 48 weeks

TMC435drug

150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 24 or 48 weeks

Peginterferon alpha-2a (PegIFN alpha-2a)drug

One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.

Ribavirin (RBV)drug

200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.