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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by BioWest Therapeutics Inc.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00332176
First received: May 30, 2006
Last updated: April 3, 2008
Last verified: April 2008
History of Changes

May 30, 2006
April 3, 2008
June 2006
December 2008   (final data collection date for primary outcome measure)
  • Safety analysis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • HCV viral load [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of celgosivir/castanospermine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety analysis
  • HCV viral load
  • Pharmacokinetics of celgosivir/castanospermine
Complete list of historical versions of study NCT00332176 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • 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
  • Experimental: 1
    Intervention: Drug: Celgosivir
  • Experimental: 2
    Intervention: Drug: Celgosivir
  • Active Comparator: 3
    Intervention: Drug: Peginterferon alfa 2b + ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Jim Pankovich 604-221-9666 ext 259
Canada
 
NCT00332176
HCV-06-001
Not Provided
Jim Pankovich, Study Director, MIGENIX Inc.
BioWest Therapeutics Inc
Not Provided
Study Director: Jim Pankovich BioWest Therapeutics Inc
BioWest Therapeutics Inc
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP