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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

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Celgosivir Drug: Peginterferon alfa 2b + ribavirin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2006
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Celgosivir
400mg qd + standard of care for 12 weeks
Experimental: 2 Drug: Celgosivir
600mg qd + standard of care for 12 weeks
Active Comparator: 3 Drug: Peginterferon alfa 2b + ribavirin
Standard of care for 12 weeks



Primary Outcome Measures :
  1. Safety analysis [ Time Frame: 12 weeks ]
  2. HCV viral load [ Time Frame: 12 weeks ]
  3. Pharmacokinetics of celgosivir/castanospermine [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332176


Contacts
Contact: Jim Pankovich 604-221-9666 ext 259

Locations
Canada, British Columbia
Liver and Intestinal Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1H2
Cantest Completed
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Ontario
Biovail Contract Research Recruiting
Toronto, Ontario, Canada, M1L 4S4
Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc

Responsible Party: Jim Pankovich, Study Director, MIGENIX Inc.
ClinicalTrials.gov Identifier: NCT00332176     History of Changes
Other Study ID Numbers: HCV-06-001
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: April 8, 2008
Last Verified: April 2008

Keywords provided by BioWest Therapeutics Inc:
Hepatitis C
Celgosivir
HCV
Genotype 1
Treatment-naive
Early viral kinetics

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs