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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

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ClinicalTrials.gov Identifier: NCT00332176
Recruitment Status : Unknown
Verified April 2008 by BioWest Therapeutics Inc.
Recruitment status was:  Recruiting
First Posted : June 1, 2006
Last Update Posted : April 8, 2008
Sponsor:
Information provided by:
BioWest Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE May 30, 2006
First Posted Date  ICMJE June 1, 2006
Last Update Posted Date April 8, 2008
Study Start Date  ICMJE June 2006
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
  • Safety analysis [ Time Frame: 12 weeks ]
  • HCV viral load [ Time Frame: 12 weeks ]
  • Pharmacokinetics of celgosivir/castanospermine [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2006)
  • Safety analysis
  • HCV viral load
  • Pharmacokinetics of celgosivir/castanospermine
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Celgosivir
  • Experimental: 2
    Intervention: Drug: Celgosivir
  • Active Comparator: 3
    Intervention: Drug: Peginterferon alfa 2b + ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 17, 2008)
50
Original Enrollment  ICMJE
 (submitted: May 30, 2006)
30
Estimated Study Completion Date  ICMJE December 2008
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332176
Other Study ID Numbers  ICMJE HCV-06-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jim Pankovich, Study Director, MIGENIX Inc.
Study Sponsor  ICMJE BioWest Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jim Pankovich BioWest Therapeutics Inc
PRS Account BioWest Therapeutics Inc
Verification Date April 2008

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