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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
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 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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Fluvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014