Back to resultsA Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Celgosivir
Celgosivir
Peginterferon alfa 2b + ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C, Celgosivir, HCV, Genotype 1, Treatment-naive, Early viral kinetics
Eligibility Criteria
Inclusion Criteria: 18-65 years of age, inclusive primary diagnosis of chronic HCV infection, genotype 1 Interferon-based treatment-naïve Body Mass Index of 18 to 30, inclusive Exclusion Criteria: patients previously treated with Interferon-based therapy patients with diabetes mellitus
Sites / Locations
- Liver and Intestinal Research CentreRecruiting
- Cantest
- Biovail Contract ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Safety analysis
HCV viral load
Pharmacokinetics of celgosivir/castanospermine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332176
Brief Title
A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
Official Title
A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
BioWest Therapeutics Inc
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Hepatitis C, Celgosivir, HCV, Genotype 1, Treatment-naive, Early viral kinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Celgosivir
Intervention Description
400mg qd + standard of care for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Celgosivir
Intervention Description
600mg qd + standard of care for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa 2b + ribavirin
Intervention Description
Standard of care for 12 weeks
Primary Outcome Measure Information:
Title
Safety analysis
Time Frame
12 weeks
Title
HCV viral load
Time Frame
12 weeks
Title
Pharmacokinetics of celgosivir/castanospermine
Time Frame
12 weeks
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, genotype 1
Interferon-based treatment-naïve
Body Mass Index of 18 to 30, inclusive
Exclusion Criteria:
patients previously treated with Interferon-based therapy
patients with diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim Pankovich
Phone
604-221-9666
Ext
259
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Pankovich
Organizational Affiliation
BioWest Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
Liver and Intestinal Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cantest
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H6
Country
Canada
Individual Site Status
Completed
Facility Name
Biovail Contract Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1L 4S4
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
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