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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by BioWest Therapeutics Inc.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332176
First Posted: June 1, 2006
Last Update Posted: April 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioWest Therapeutics Inc
  Purpose
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 Intervention Phase
Chronic Hepatitis C Drug: Celgosivir Drug: Peginterferon alfa 2b + ribavirin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by BioWest Therapeutics Inc:

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

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Jim Pankovich, Study Director, MIGENIX Inc.
ClinicalTrials.gov Identifier: NCT00332176     History of Changes
Other Study ID Numbers: HCV-06-001
First Submitted: May 30, 2006
First Posted: June 1, 2006
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