HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01377909
• Other study ID #: Bader 15859
• Status: Terminated
• Phase: Phase 1
• First received: June 20, 2011
• Last updated: August 21, 2013
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Bader, Ted, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• statin
daily statin orally for 48 weeks

Locations

Country	Name	City	State
United States	Veterans Administration Medical Center (VAMC)	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bader, Ted, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 weeks	No
Secondary	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.	48 weeks	No