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Simvastatin for the Treatment of Chronic Hepatitis B

This study has been completed.
Information provided by (Responsible Party):
Ted Bader, MD, Bader, Ted, M.D. Identifier:
First received: October 10, 2009
Last updated: August 15, 2012
Last verified: August 2012
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.

Condition Intervention Phase
Hepatitis B Drug: Simvastatin Drug: Tenofovir Drug: Entecavir Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B

Resource links provided by NLM:

Further study details as provided by Ted Bader, MD, Bader, Ted, M.D.:

Primary Outcome Measures:
  • Reduction of HBV DNA by one log. [ Time Frame: 14 days ]
    Simvastatin will be given in doses of 5,10,20,and 40mg per day

Secondary Outcome Measures:
  • Alanine aminotransferase (ALT) reduction [ Time Frame: 14 days ]
    ALT changes will be noted

Enrollment: 32
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin
Simvastatin orally
Drug: Simvastatin
daily doses for 14 days
Other Name: Zocor
Experimental: Simvastatin and tenofovir
Simvastatin combined with tenofovir
Drug: Simvastatin
daily doses for 14 days
Other Name: Zocor
Drug: Tenofovir
Experimental: Simvastatin and entecavir
Simvastatin combined with entecavir
Drug: Simvastatin
daily doses for 14 days
Other Name: Zocor
Drug: Entecavir


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00994773

United States, Oklahoma
VA Medical Center
Oklahoma City, Oklahoma, United States, 74104
Sponsors and Collaborators
Bader, Ted, M.D.
Principal Investigator: Teddy Bader, M.D. University of Oklahoma
  More Information

Responsible Party: Ted Bader, MD, Director of Liver Diseases, OUHSC/VAMC, Bader, Ted, M.D. Identifier: NCT00994773     History of Changes
Other Study ID Numbers: HBV 14934
Simvastatin against HepB
Study First Received: October 10, 2009
Last Updated: August 15, 2012

Keywords provided by Ted Bader, MD, Bader, Ted, M.D.:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors processed this record on September 19, 2017