HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
|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.|
|ClinicalTrials.gov Identifier: NCT01377909|
Recruitment Status : Terminated (Principal Investigator retiring)
First Posted : June 22, 2011
Last Update Posted : August 22, 2013
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
daily statin orally for 48 weeks
- 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.
- 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.
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
|United States, Oklahoma|
|Veterans Administration Medical Center (VAMC)|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Ted Bader, M.D.||VA Office of Research and Development|