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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292084
First Posted: February 15, 2006
Last Update Posted: January 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioWest Therapeutics Inc
February 13, 2006
February 15, 2006
January 21, 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
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00292084
HCV-05-004
Not Provided
Not Provided
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