Status:
COMPLETED
Simvastatin for the Treatment of Chronic Hepatitis B
Lead Sponsor:
Bader, Ted, M.D.
Conditions:
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The investigators pr...
Eligibility Criteria
Inclusion
- Hepatitis B positive by HBV DNA within 180 days.
- Ages 18-70.
- Men and non-pregnant women eligible.
- Veteran's eligibility or appropriate health insurance.
Exclusion
- Use of any anti-HBV medicine within 30 days.
- Decompensated cirrhosis as evidenced by esophageal varices, ascites, or encephalopathy. (grade 1 varices without history of bleeding will be allowed, if patient meets Child's-Pugh functional classification grade A).
- A positive urine test for marijuana or alcohol within 2 months of screening.(Allowed to repeat tests on different days, if positive first time in order to become eligible for study.
- Severe cardiovascular disease (ejection fraction \<20%)\* or uncontrolled angina.
- Severe pulmonary disease (FEV1 \< 1.0).
- Chronic renal insufficiency (creatinine clearance \<50 ml/min.
- HIV positive patients.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00994773
Start Date
December 1 2009
End Date
December 1 2011
Last Update
August 16 2012
Active Locations (1)
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1
VA Medical Center
Oklahoma City, Oklahoma, United States, 74104