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NCT00441493 Clinical Trial

Fluvastatin Versus Hepatitis C Virus

Hepatitis C Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00441493
Other study ID # 13035
Secondary ID 13134
Status Completed
Phase N/A
First received February 27, 2007
Last updated July 26, 2012
Start date September 2006
Est. completion date September 2007

Study information
Verified date September 2006
Source Bader, Ted, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date September 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- HCV RNA positive

Exclusion Criteria:

- Testing positive for alcohol or marijuana

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• fluvastatin

Locations
Country Name City State
United States VA Medical Center Oklahoma City Oklahoma

Sponsors (2)
Lead Sponsor Collaborator
Bader, Ted, M.D. VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Viral Load Reduction, Liver test changes
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