Back to resultsA 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, Early Viral Response, EVR
Eligibility Criteria
Inclusion Criteria: 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
Secondary Outcome Measures
Full Information
NCT ID
NCT00217139
First Posted
September 13, 2005
Last Updated
September 27, 2006
Sponsor
BioWest Therapeutics Inc
1. Study Identification
Unique Protocol Identification Number
NCT00217139
Brief Title
A 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, Randomized, Active-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With and Without Ribavirin, for 12 Weeks in Patients With Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-Based Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
BioWest Therapeutics Inc
4. Oversight
5. Study Description
Brief Summary
The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 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, Early Viral Response, EVR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
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
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:
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
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A 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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