An Extension 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:
NCT00292084
First received: February 13, 2006
Last updated: January 17, 2008
Last verified: January 2008
  Purpose

This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 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: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multi-Center, Extension Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With or Without Ribavirin, for an Additional 36 Weeks

Resource links provided by NLM:


Further study details as provided by BioWest Therapeutics Inc:

Primary Outcome Measures:
  • Safety analysis
  • HCV viral load reduction from baseline

Estimated Enrollment: 60
Study Start Date: February 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed HCV-05-002 only
  • 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: NCT00292084

Locations
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
BioWest Therapeutics Inc
Investigators
Study Director: Jim Pankovich BioWest Therapeutics Inc
  More Information

No publications provided

Responsible Party: Jim Pankovich, MIGENIX Inc.
ClinicalTrials.gov Identifier: NCT00292084     History of Changes
Other Study ID Numbers: HCV-05-004
Study First Received: February 13, 2006
Last Updated: January 17, 2008
Health Authority: Canada: Health Canada

Keywords provided by BioWest Therapeutics Inc:
Hepatitis C
Celgosivir
HCV
Genotype 1
Non-responders
End of Treatment Response
Sustained Viral Response

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
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 April 17, 2014