Recruiting

Phase 2

Celgosivir & PeginterferonA 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

Sponsor:

BioWest Therapeutics Inc

Code:

NCT00332176

Conditions

Chronic Hepatitis C

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Celgosivir

Peginterferon alfa 2b + ribavirin

Study Details

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.

Conditions

Chronic Hepatitis C

Study ID

NCT00332176

Start date

Jun, 2006

Status verified date

Apr, 2008

Completion date

Dec, 2008

Anticipated

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

experimental: 2

active comparator: 3

Interventions

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

Primary outcome measure

Safety analysis [ Time Frame: 12 weeks ]
HCV viral load [ Time Frame: 12 weeks ]
Pharmacokinetics of celgosivir/castanospermine [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Jim Pankovich

604-221-9666

Locations

Liver and Intestinal Research Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1H2

Biovail Contract Research

Recruiting

Toronto, Ontario, Canada, M1L 4S4

More Information

Sponsor

BioWest Therapeutics Inc

Last update posted

Apr 8, 2008

Last verified

Apr, 2008

Keywords

Hepatitis C
Celgosivir
HCV
Genotype 1
Treatment-naive
Early viral kinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BioWest Therapeutics Inc on 2008-04-08.