Fluvastatin Versus Hepatitis C Virus

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bader, Ted, M.D.
ClinicalTrials.gov Identifier:
NCT00441493
First received: February 27, 2007
Last updated: July 26, 2012
Last verified: September 2006
  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 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.

  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.
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: July 26, 2012
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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 April 15, 2014