- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441493
Fluvastatin Versus Hepatitis C Virus
July 26, 2012 updated by: Bader, Ted, M.D.
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.
This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.
Study Overview
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.
Study Type
Interventional
Enrollment
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HCV RNA positive
Exclusion Criteria:
- Testing positive for alcohol or marijuana
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Viral Load Reduction, Liver test changes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ted Bader, MD, VA Medical Center and University of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
February 27, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Estimate)
July 27, 2012
Last Update Submitted That Met QC Criteria
July 26, 2012
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13035
- 13134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.