Back to resultsHCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
Primary Purpose
Chronic Hepatitis C
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
statin
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Hepatitis C focused on measuring chronic hepatitis C, interferon
Eligibility 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)
Sites / Locations
- Veterans Administration Medical Center (VAMC)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
statin
Arm Description
Outcomes
Primary Outcome Measures
Improvement in peginterferon response as measured by change in HCV RNA levels
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377909
Brief Title
HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator retiring
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bader, Ted, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
chronic hepatitis C, interferon
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
statin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
statin
Intervention Description
daily statin orally for 48 weeks
Primary Outcome Measure Information:
Title
Improvement in peginterferon response as measured by change in HCV RNA levels
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
The response of interferon stimulated genes
Description
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.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Bader, M.D.
Organizational Affiliation
VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Administration Medical Center (VAMC)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
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