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Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487318
First Posted: June 18, 2007
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Ted Bader, MD, Bader, Ted, M.D.
  Purpose
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.

Condition Intervention Phase
Chronic Hepatitis C Drug: standard of care Drug: fluvastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sustained Viral response [ Time Frame: 72 weeks ]

Secondary Outcome Measures:
  • Viral load at 4, 12 and 24 weeks [ Time Frame: 24 weeks ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Plus statin
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
Drug: fluvastatin
Add fluvastatin at 20-40 mg/day to standard of care
Other Name: Lescol
Active Comparator: 2
Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
Drug: standard of care
peginterferon/RBV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not previously treated.
  • Off alcohol and marijuana for 6 months
  • HCV RNA positive

Exclusion Criteria:

  • HIV positive
  • Advanced liver disease
  • Advanced cardiopulmonary disease
  • Chronic renal failure
  Contacts and Locations
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): NCT00487318


Locations
United States, Oklahoma
Veterans Administration 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 F Bader, MD OUHSC and VAMC
  More Information

Responsible Party: Ted Bader, MD, Director of Liver Diseases, VA Medical Center, Bader, Ted, M.D.
ClinicalTrials.gov Identifier: NCT00487318     History of Changes
Other Study ID Numbers: 13358
First Submitted: June 15, 2007
First Posted: June 18, 2007
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Ted Bader, MD, Bader, Ted, M.D.:
fluvastatin
hepatitis C
chronic hepatitis C
not previously treated with pegylated interferon and ribavirin

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