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Simvastatin for the Treatment of Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT00994773
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : August 16, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Simvastatin Drug: Tenofovir Drug: Entecavir Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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
Study Start Date : December 2009
Primary Completion Date : October 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Alanine aminotransferase (ALT) reduction [ Time Frame: 14 days ]
    ALT changes will be noted

Eligibility Criteria

Information from the National Library of Medicine

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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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
ClinicalTrials.gov Identifier: NCT00994773     History of Changes
Other Study ID Numbers: HBV 14934
Simvastatin against HepB
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 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