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HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

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ClinicalTrials.gov Identifier: NCT01377909
Recruitment Status : Terminated (Principal Investigator retiring)
First Posted : June 22, 2011
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Ted Bader, MD, Bader, Ted, M.D.

Brief Summary:

Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.

Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: statin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders
Study Start Date : March 2012
Estimated Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: statin Drug: statin
daily statin orally for 48 weeks




Primary Outcome Measures :
  1. Improvement in peginterferon response as measured by change in HCV RNA levels [ Time Frame: 48 weeks ]
    The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically.


Secondary Outcome Measures :
  1. The response of interferon stimulated genes [ Time Frame: 48 weeks ]
    The number of known interferon activated genes will be assessed by microarray from serum samples at baseline and then reassessed by microarray 48 weeks later.



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

Inclusion Criteria:

Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening

Exclusion Criteria:

  • decompensated liver disease
  • severe cardiac disease (ejection fraction < 20% or uncontrolled angina)
  • unexplained muscle pain at time of screening
  • pregnancy
  • renal insufficiency (creatine clearance < 50 ml/min)

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): NCT01377909


Locations
United States, Oklahoma
Veterans Administration Medical Center (VAMC)
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Bader, Ted, M.D.
Investigators
Principal Investigator: Ted Bader, M.D. VA Office of Research and Development

Responsible Party: Ted Bader, MD, Director of Liver Diseases, Professor, Department of Medicine, Section of Gastroenterology, Bader, Ted, M.D.
ClinicalTrials.gov Identifier: NCT01377909     History of Changes
Other Study ID Numbers: Bader 15859
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Ted Bader, MD, Bader, Ted, M.D.:
chronic hepatitis C, interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
Peginterferon alfa-2b
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents