NCT00332176
Unknown
Phase 2
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
BioWest Therapeutics Inc3 sites in 1 country50 target enrollmentJune 2006
ConditionsChronic Hepatitis C
Overview
- Phase
- Phase 2
- Intervention
- Celgosivir
- Conditions
- Chronic Hepatitis C
- Sponsor
- BioWest Therapeutics Inc
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Safety analysis
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
1
Intervention: Celgosivir
2
Intervention: Celgosivir
3
Intervention: Peginterferon alfa 2b + ribavirin
Outcomes
Primary Outcomes
Safety analysis
Time Frame: 12 weeks
HCV viral load
Time Frame: 12 weeks
Pharmacokinetics of celgosivir/castanospermine
Time Frame: 12 weeks
Study Sites (3)
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