Text Size

A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

This study has been completed.
Sponsor:
Information provided by:
BioWest Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00217139
First received: September 13, 2005
Last updated: September 27, 2006
Last verified: September 2006
History of Changes
  Purpose

The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: Celgosivir
 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, Multi-Center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With and Without Ribavirin, for 12 Weeks in Patients With Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-Based Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioWest Therapeutics Inc:

Primary Outcome Measures:
  • Safety analysis
  • HCV viral load

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
  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
  • non-responders to previous pegylated interferon-based therapy

Exclusion Criteria:

  • patients naive to interferon-based therapy for chronic HCV infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217139

Locations
Canada, Alberta
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
London, Ontario, Canada
Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00217139     History of Changes
Other Study ID Numbers: HCV-05-002
Study First Received: September 13, 2005
Last Updated: September 27, 2006
Health Authority: Canada: Health Canada

Keywords provided by BioWest Therapeutics Inc:
Hepatitis C
Celgosivir
HCV
Genotype 1
 Non-responders
Early Viral Response
EVR

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

ClinicalTrials.gov processed this record on May 21, 2013