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Simvastatin for the Treatment of Chronic Hepatitis B

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ted Bader, MD, Bader, Ted, M.D.
ClinicalTrials.gov Identifier:
NCT00994773
First received: October 10, 2009
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Bader, Ted, M.D.:

Primary Outcome Measures:
  • Reduction of HBV DNA by one log. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Entecavir

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994773

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

No publications provided

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
Study First Received: October 10, 2009
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Bader, Ted, M.D.:
Hepatitis B
simvastatin
HBV DNA

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Entecavir
Simvastatin
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Anticholesteremic Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014