At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
TMC435drug
Likely dose
TMC435 200 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.
An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.
In Brief
A Phase 2 clinical trial evaluating TMC435 for Hepatitis C. Completed, enrolled 37 participants across 10 sites in 3 countries.
Detailed Summary
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesBelgium, Germany, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartMar 2009
Primary CompletionNov 2009
TodayJul 2026
First PostedDec 22, 2008
Enrollment StartMar 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.5 years ago
Interventions
TMC435drug
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.