NCT00332176

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: BioWest Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Celgosivir	400mg qd + standard of care for 12 weeks
DRUG	Celgosivir	600mg qd + standard of care for 12 weeks
DRUG	Peginterferon alfa 2b + ribavirin	Standard of care for 12 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-06-01
• Last updated: 2008-04-08

Locations

3 sites across 1 country: Canada