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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

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ClinicalTrials.gov Identifier: NCT00292084
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : January 21, 2008
Information provided by:
BioWest Therapeutics Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Celgosivir Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2006
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Safety analysis
  2. HCV viral load reduction from baseline

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

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

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): NCT00292084

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

Responsible Party: Jim Pankovich, MIGENIX Inc.
ClinicalTrials.gov Identifier: NCT00292084     History of Changes
Other Study ID Numbers: HCV-05-004
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: January 21, 2008
Last Verified: January 2008

Keywords provided by BioWest Therapeutics Inc:
Hepatitis C
Genotype 1
End of Treatment Response
Sustained Viral Response

Additional relevant MeSH terms:
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
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs