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
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: 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 August 20, 2014