CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 393 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/NCT01290679
NCT01290679Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

Janssen R&D Ireland·interventional·Posted Feb 7, 2011·Updated Jun 13, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo, TMC435, and 2 other interventions for Hepatitis C. Completed, enrolled 393 participants across 60 sites in 15 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 alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, France, Germany, Netherlands, Poland, Portugal, Puerto Rico, Slovakia, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartMar 1, 2011
Primary CompletionFeb 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 peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks

TMC435drug

150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks

Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)drug

One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.

Ribavirin (RBV)drug

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