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

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioWest Therapeutics Inc
• Treatments: Antiviral Agents; Interferon-alpha; Peginterferon alfa-2b; Ribavirin

Criteria

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