Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive (CLEAN-1)
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 Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Evaluate the pharmacodynamic (PD) activity of a 100 mg po BID dose of clemizole hydrochloride on HCV viral load [ Time Frame: Day 1, 3, 7, 14, 28, 56 ] [ Designated as safety issue: No ]
- Evaluate the pharmacokinetics (PK) of a 100 mg po BID dose of clemizole hydrochloride in subjects chronically infected with HCV [ Time Frame: Day 1 and Day 28 ] [ Designated as safety issue: No ]
- Evaluate the safety and tolerability of four weeks of treatment with a 100 mg po BID dose of clemizole hydrochloride through review of adverse events [ Time Frame: Day 1, 2, 3, 7, 14, 28, 56 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Drug: clemizole hydrochloride
This study is a phase 1b, open label study of four weeks of treatment with 100 mg po BID of clemizole hydrochloride administered immediately prior to the initiation of treatment with HCV standard of care therapy consisting of pegylated interferon and ribavirin in treatment-naïve subjects chronically infected with HCV genotype 1 or genotype 2. The duration of the study for each subject will be approximately 11 weeks (up to three week screening period, four week treatment period and four week safety follow-up period). The duration of the entire study is anticipated to be approximately four months (first subject in to last subject out). Pharmacokinetic sampling will be done at Day 1 and Day 28 of dosing. PK sampling will be conducted only on subjects who have consented to participate in the PK portion of this study. Participation in PK sampling is optional for each subject.