At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
clemizole hydrochloridedrug
Likely dose
clemizole hydrochloride 50 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.
A Phase 1b, Open Label Study of the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of 100 mg Clemizole Hydrochloride Administered Orally Twice a Day for 28 Days Immediately Prior to Initiation of Treatment With HCV Standard of Care Therapy in Treatment-Naïve Subjects Chronically Infected With HCV
In Brief
A Phase 1 clinical trial evaluating clemizole hydrochloride for Hepatitis C. Completed, enrolled 12 participants.
Detailed Summary
The purpose of this study is to test the hypothesis that clemizole hydrochloride is safe and well tolerated when administered to subjects who are infected with hepatitis C virus and have not yet received treatment. This study will also examine how the virus and body respond to clemizole hydrochloride.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedJul 24, 2009
Enrollment StartJul 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.9 years ago
Interventions
clemizole hydrochloridedrug
Two 50 mg capsules containing clemizole hydrochloride are to be administered orally twice a day for 28 days for a total daily dose of 200 mg. Followed immediately by standard of care treatment consisting of interferon and ribavirin