An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

Phase 2

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00292084
• Lead Sponsor: BioWest Therapeutics Inc

Brief Summary

This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-15
• Study Completion: 2007-10
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-17
• Last Update Posted: 2008-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who completed HCV-05-002 only
• 18-65 years of age, inclusive
• Primary diagnosis of chronic HCV infection
• Non-responders to previous pegylated interferon-based therapy

Exclusion Criteria

• Patients naive to interferon-based therapy for chronic HCV infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety analysis
HCV viral load reduction from baseline