Simvastatin for the Treatment of Chronic Hepatitis B

A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994773

Enrollment

Registered

2009-10-14

Start date

2009-12-31

Completion date

2011-12-31

Last updated

2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, simvastatin, HBV DNA

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 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.

Interventions

DRUGSimvastatin

daily doses for 14 days

DRUGTenofovir

DRUGEntecavir

Entecavir

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction of HBV DNA by one log.	14 days	Simvastatin will be given in doses of 5,10,20,and 40mg per day

Secondary

Measure	Time frame	Description
Alanine aminotransferase (ALT) reduction	14 days	ALT changes will be noted

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026