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Fluvastatin Versus Hepatitis C Virus

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ClinicalTrials.gov Identifier: NCT00441493
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : July 27, 2012
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by:
Bader, Ted, M.D.

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: fluvastatin Not Applicable

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  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : September 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Viral Load Reduction, Liver test changes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV RNA positive

Exclusion Criteria:

  • Testing positive for alcohol or marijuana

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441493


Locations
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
Investigators
Principal Investigator: Ted Bader, MD VA Medical Center and University of Oklahoma

ClinicalTrials.gov Identifier: NCT00441493     History of Changes
Other Study ID Numbers: 13035
13134
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: September 2006

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

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