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Simvastatin for the Treatment of Chronic Hepatitis B
This study is not yet open for participant recruitment.
Verified by Bader, Ted, M.D., October 2009
First Received: October 10, 2009   Last Updated: October 13, 2009   History of Changes
Sponsor: Bader, Ted, M.D.
Information provided by: Bader, Ted, M.D.
ClinicalTrials.gov Identifier: NCT00994773
  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 I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 ]

Secondary Outcome Measures:
  • Alanine aminotransferase (ALT) reduction [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Simvastatin: Experimental
Simvastatin orally
Drug: Simvastatin
daily doses for 14 days
Simvastatin and tenofovir: Experimental
Simvastatin combined with tenofovir
Drug: Simvastatin
daily doses for 14 days
Drug: Tenofovir
Simvastatin and entecavir: Experimental
Simvastatin combined with entecavir
Drug: Simvastatin
daily doses for 14 days
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994773

Contacts
Contact: Paula Allen, MA 405-456-3982 Paula.Allen@va.gov
Contact: Joe Cardello, PA 405-456-3982 Joe-Cardello@va.gov

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: University of Oklahoma Health Sciences Center/VA Medical Center ( Ted Bader, M.D., Director of Liver Diseases, )
Study ID Numbers: HBV 106707
Study First Received: October 10, 2009
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00994773     History of Changes
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Hepadnaviridae Infections
Reverse Transcriptase Inhibitors
Entecavir
Anti-Retroviral Agents
Hepatitis B, Chronic
Therapeutic Uses
Hepatitis B
Tenofovir
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
Anti-HIV Agents
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antiviral Agents
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
DNA Virus Infections

ClinicalTrials.gov processed this record on February 08, 2010