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Fluvastatin Versus Hepatitis C Virus

This study has been completed.
VA Office of Research and Development
Information provided by:
Bader, Ted, M.D. Identifier:
First received: February 27, 2007
Last updated: July 26, 2012
Last verified: September 2006
This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.

Condition Intervention
Hepatitis C
Drug: fluvastatin

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

Resource links provided by NLM:

Further study details as provided by Bader, Ted, M.D.:

Primary Outcome Measures:
  • Viral Load Reduction, Liver test changes

Estimated Enrollment: 32
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HCV RNA positive

Exclusion Criteria:

  • Testing positive for alcohol or marijuana
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00441493

United States, Oklahoma
VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Bader, Ted, M.D.
VA Office of Research and Development
Principal Investigator: Ted Bader, MD VA Medical Center and University of Oklahoma
  More Information Identifier: NCT00441493     History of Changes
Other Study ID Numbers: 13035  13134 
Study First Received: February 27, 2007
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bader, Ted, M.D.:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on October 21, 2016