Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332176

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

Locations
Canada, British Columbia
Cantest Completed
Vancouver, British Columbia, Canada, V5Z 1H6
Liver and Intestinal Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1H2
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

No publications provided

Responsible Party: Jim Pankovich, Study Director, MIGENIX Inc.
ClinicalTrials.gov Identifier: NCT00332176     History of Changes
Other Study ID Numbers: HCV-06-001
Study First Received: May 30, 2006
Last Updated: April 3, 2008
Health Authority: Canada: Health Canada

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 C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014