This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.
..Date First Received: February 27, 2007
Last Updated: February 28, 2007
Verified by: Bader, Ted, M.D., February 2007
Clinical Trial Phase: N/A | Start Date: September 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 32
Brief Summary
Official Title: “A Dose Finding Study of Fluvastatin for in Vivo Demonstration of Inhibiting Hepatitis C Replication in Patients Infected With Chronic Hepatitis C”
Condition Keyword(s):
Intervention(s):
This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: fluvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- Viral Load Reduction, Liver test changes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- HCV RNA positive
Exclusion Criteria:
- Testing positive for alcohol or marijuana
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bader, Ted, M.D.
Overall Clinical Trial Officials and Contacts
Ted Bader, MD Principal Investigator VA Medical Center and University of Oklahoma
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441493
Study ID Number: 13035
ClinicalTrials.gov Identifier: NCT00441493
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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