A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection

Phase 2

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00157534
• Lead Sponsor: BioWest Therapeutics Inc

Brief Summary

The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Last Update Submitted: 2005-09-07
• Study First Posted: 2005-09-12
• Last Update Posted: 2005-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• The patient must be 18 to 65 years of age, inclusive.
• Primary diagnosis of chronic HCV infection.

Exclusion Criteria

• Patients who did not respond or relapsed following therapy with interferon.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety analysis

Secondary Outcome Measures

Name	Time	Method
Hepatitis C viral load