CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 386 enrolled
Drug / intervention
TMC435 +3 moredrug
Likely dose
TMC435 75 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/NCT00882908
NCT00882908Phase 2Completed
CompareCT.gov

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects

Tibotec Pharmaceuticals, Ireland·interventional·Posted Apr 17, 2009·Updated Jun 16, 2014

In Brief

A Phase 2 clinical trial evaluating TMC435, Ribavirin (R), and 2 other interventions for Hepatitis C. Completed, enrolled 386 participants across 71 sites in 13 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, New Zealand, Norway, Poland, Russia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.2 years ago

Interventions

TMC435drug

TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.

Ribavirin (R)drug

Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.

PegIFNα-2a (P)drug

PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.

Placebodrug

Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.