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Simvastatin for the Treatment of Chronic Hepatitis B

NCT ID: NCT00994773

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B

Keywords

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Hepatitis B simvastatin HBV DNA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simvastatin

Simvastatin orally

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

daily doses for 14 days

Simvastatin and tenofovir

Simvastatin combined with tenofovir

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

daily doses for 14 days

Tenofovir

Intervention Type DRUG

Simvastatin and entecavir

Simvastatin combined with entecavir

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

daily doses for 14 days

Entecavir

Intervention Type DRUG

Entecavir

Interventions

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Simvastatin

daily doses for 14 days

Intervention Type DRUG

Tenofovir

Intervention Type DRUG

Entecavir

Entecavir

Intervention Type DRUG

Other Intervention Names

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Zocor

Eligibility 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bader, Ted, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Ted Bader, MD

Director of Liver Diseases, OUHSC/VAMC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Teddy Bader, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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VA Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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Simvastatin against HepB

Identifier Type: -

Identifier Source: secondary_id

HBV 14934

Identifier Type: -

Identifier Source: org_study_id