Simvastatin for the Treatment of Chronic Hepatitis B
Information source: Bader, Ted, M.D.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: Simvastatin (Drug); Tenofovir (Drug); Entecavir (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Bader, Ted, M.D. Official(s) and/or principal investigator(s):
Teddy Bader, M.D., Principal Investigator, Affiliation: University of Oklahoma
Overall contact:
Paula Allen, MA, Phone: 405-456-3982, Email: Paula.Allen@va.gov
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 propose phase 1 studies in 48 chronic hepatitis B human carriers who have
never been treated before. Doses of drugs will remain at or below FDA-approved dosage levels
for cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will
have simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will
combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in
each arm will be filled consecutively and not concurrently. The definition of efficacy for
simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for
combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous
safety tests and stop rules are noted in the protocol.
Clinical Details
Official title: A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Reduction of HBV DNA by one log.
Secondary outcome: Alanine aminotransferase (ALT) reduction
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Hepatitis B positive by HBV DNA within 180 days.
2. Ages 18-70.
3. Men and non-pregnant women eligible.
4. Veteran's eligibility or appropriate health insurance.
Exclusion Criteria:
1. Use of any anti-HBV medicine within 30 days.
2. 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).
3. 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.
4. Severe cardiovascular disease (ejection fraction <20%)* or uncontrolled angina.
5. Severe pulmonary disease (FEV1 < 1. 0).
6. Chronic renal insufficiency (creatinine clearance <50 ml/min.
7. HIV positive patients.
Locations and Contacts
Paula Allen, MA, Phone: 405-456-3982, Email: Paula.Allen@va.gov
VA Medical Center, Oklahoma City, Oklahoma 74104, United States
Additional Information
Starting date: January 2010
Ending date: January 2013
Last updated: October 13, 2009
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