A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B
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| City: |
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Oklahoma City |
| State: |
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Oklahoma |
| Zip Code: |
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74104 |
| Conditions: |
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Hepatitis B |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT00994773 |
| Primary Contact: |
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Principal Investigator
Teddy Bader, M.D.
University of Oklahoma
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| Backup Contact: |
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N/A |
| Location Contact: |
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Oklahoma City, Oklahoma 74104
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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