Hepatitis B Clinical Trial
Official title:
A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B
Verified date | August 2012 |
Source | Bader, Ted, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Bader, Ted, M.D. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of HBV DNA by one log. | Simvastatin will be given in doses of 5,10,20,and 40mg per day | 14 days | No |
Secondary | Alanine aminotransferase (ALT) reduction | ALT changes will be noted | 14 days | Yes |
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