Back to resultsAn 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
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Celgosivir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Celgosivir, HCV, Genotype 1, Non-responders, End of Treatment Response, Sustained Viral Response
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Safety analysis
HCV viral load reduction from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00292084
First Posted
February 13, 2006
Last Updated
January 17, 2008
Sponsor
BioWest Therapeutics Inc
1. Study Identification
Unique Protocol Identification Number
NCT00292084
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
BioWest Therapeutics Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, Celgosivir, HCV, Genotype 1, Non-responders, End of Treatment Response, Sustained Viral Response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Celgosivir
Primary Outcome Measure Information:
Title
Safety analysis
Title
HCV viral load reduction from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Pankovich
Organizational Affiliation
BioWest Therapeutics Inc
Official's Role
Study Director
Facility Information:
City
Halifax
State/Province
Nova Scotia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
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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