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

February 13, 2006
January 17, 2008
February 2006
Not Provided
  • Safety analysis
  • HCV viral load reduction from baseline
Same as current
Complete list of historical versions of study NCT00292084 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
Drug: Celgosivir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00292084
HCV-05-004
Not Provided
Jim Pankovich, MIGENIX Inc.
BioWest Therapeutics Inc
Not Provided
Study Director: Jim Pankovich BioWest Therapeutics Inc
BioWest Therapeutics Inc
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP