Fluvastatin Versus Hepatitis C Virus

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2007 by Bader, Ted, M.D.. Recruitment status was Active, not recruiting

First Received on February 27, 2007. Last Updated on February 28, 2007 History of Changes

Sponsor:	Bader, Ted, M.D.
Collaborator:	Department of Veterans Affairs
Information provided by:	Bader, Ted, M.D.
ClinicalTrials.gov Identifier:	NCT00441493

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Fluvastatin Hepatitis A Vaccines

U.S. FDA Resources

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
Estimated Study Completion Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HCV RNA positive

Exclusion Criteria:

Testing positive for alcohol or marijuana

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441493

Locations

United States, Oklahoma
VA Medical Center
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

Bader, Ted, M.D.

Department of Veterans Affairs

Investigators

Principal Investigator:

Ted Bader, MD

VA Medical Center and University of Oklahoma

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00441493 History of Changes
Other Study ID Numbers:	13035, 13134
Study First Received:	February 27, 2007
Last Updated:	February 28, 2007
Health Authority:	United States: Food and Drug Administration

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

Hepatitis C
fluvastatin

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Hepatitis, Chronic
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012