NCT00945880

Safety and Tolerability Study of Clemizole Hydrochloride to Treat Hepatitis C in Subjects Who Are Treatment-Naive

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Eiger BioPharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	clemizole hydrochloride	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

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-07-24
• Last updated: 2021-04-15