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

Chronic Hepatitis C Clinical Trial

Official title:

A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00332176
• Other study ID #: HCV-06-001
• Status: Recruiting
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: April 3, 2008
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: BioWest Therapeutics Inc
• Contact: Jim Pankovich
• Phone: 604-221-9666
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Celgosivir
400mg qd + standard of care for 12 weeks
• Celgosivir
600mg qd + standard of care for 12 weeks
• Peginterferon alfa 2b + ribavirin
Standard of care for 12 weeks

Locations

Country	Name	City	State
Canada	Biovail Contract Research	Toronto	Ontario
Canada	Cantest	Vancouver	British Columbia
Canada	Liver and Intestinal Research Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BioWest Therapeutics Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety analysis		12 weeks	Yes
Primary	HCV viral load		12 weeks	Yes
Primary	Pharmacokinetics of celgosivir/castanospermine		12 weeks	No