HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

This study has been terminated.
(Principal Investigator retiring)
Sponsor:
Information provided by (Responsible Party):
Ted Bader, MD, Bader, Ted, M.D.
ClinicalTrials.gov Identifier:
NCT01377909
First received: June 20, 2011
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: statin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement in peginterferon response as measured by change in HCV RNA levels [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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:
  • The response of interferon stimulated genes [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: March 2012
Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: statin Drug: statin
daily statin orally for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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. Department of Veterans Affairs
  More Information

No publications provided

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
Study First Received: June 20, 2011
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 21, 2014