Back to resultsFluvastatin Versus Hepatitis C Virus
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, fluvastatin
Eligibility Criteria
Inclusion Criteria:
- HCV RNA positive
Exclusion Criteria:
- Testing positive for alcohol or marijuana
Sites / Locations
- VA Medical Center
Outcomes
Primary Outcome Measures
Viral Load Reduction, Liver test changes
Secondary Outcome Measures
Full Information
NCT ID
NCT00441493
First Posted
February 27, 2007
Last Updated
July 26, 2012
Sponsor
Bader, Ted, M.D.
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00441493
Brief Title
Fluvastatin Versus Hepatitis C Virus
Official Title
A Dose Finding Study of Fluvastatin for in Vivo Demonstration of Inhibiting Hepatitis C Replication in Patients Infected With Chronic Hepatitis C With Special Attention to the African-American Population.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bader, Ted, M.D.
Collaborators
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.
Detailed Description
Four different oral doses of fluvastatin will be used for 14 days and the viral load of hepatitis C will be measured weekly. This has been extended to different doses for 9-12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, fluvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluvastatin
Primary Outcome Measure Information:
Title
Viral Load Reduction, Liver test changes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCV RNA positive
Exclusion Criteria:
Testing positive for alcohol or marijuana
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Bader, MD
Organizational Affiliation
VA Medical Center and University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
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Fluvastatin Versus Hepatitis C Virus
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