CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 121 enrolled
Drug / intervention
TMC435 +3 moredrug
Likely dose
TMC435 25 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/NCT00561353
NCT00561353Phase 2Completed
CompareCT.gov

A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin

Tibotec Pharmaceuticals, Ireland·interventional·Posted Nov 20, 2007·Updated May 20, 2014

In Brief

A Phase 2 clinical trial evaluating TMC435, Placebo, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 121 participants across 24 sites in 6 countries.

Detailed Summary

The purpose of this study is to investigate how efficient TMC435350 will work against the Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and what the concentrations of TMC435350 in the blood are with or without pegylated interferon alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBelgium, France, Germany, Netherlands, Poland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2007
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2008
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.6 years ago

Interventions

TMC435drug

TMC435 25 mg, 75 mg, 150 mg, or 200 mg capsules taken orally (by mouth) once daily for 21 or 28 days.

Placebodrug

Placebo capsules identical in appearance to TMC435 capsules taken orally (by mouth) once daily for 28 days.

Peginterferon (PegIFNα-2a)drug

One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFNα-2a on Days 1, 8, 15, and 22

Ribavirindrug

200-mg tablets of ribavirin (body-weight adjusted dose) taken orally (by mouth) twice daily for 21 or 28 days in Cohorts 1 and 2 and for 28 days in Cohorts 4 and 5.