A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C

Phase 2

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Celgosivir; Drug: Peginterferon alfa 2b + ribavirin

• Registration Number: NCT00332176
• Lead Sponsor: BioWest Therapeutics Inc

Brief Summary

The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study Start: 2006-06
• Study First Posted: 2006-06-01
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-03
• Last Update Posted: 2008-04-08
• Primary Completion: 2008-12
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18-65 years of age, inclusive
• primary diagnosis of chronic HCV infection, genotype 1
• Interferon-based treatment-naïve
• Body Mass Index of 18 to 30, inclusive

Exclusion Criteria

• patients previously treated with Interferon-based therapy
• patients with diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Celgosivir	-
3	Peginterferon alfa 2b + ribavirin	-
2	Celgosivir	-

Primary Outcome Measures

Name	Time	Method
HCV viral load	12 weeks
Safety analysis	12 weeks
Pharmacokinetics of celgosivir/castanospermine	12 weeks

Trial Locations

Locations (3)

Cantest; 🇨🇦 Vancouver, British Columbia, Canada

Biovail Contract Research; 🇨🇦 Toronto, Ontario, Canada

Liver and Intestinal Research Centre; 🇨🇦 Vancouver, British Columbia, Canada