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Completed

NCT Number: NCT00994773

Simvastatin for the Treatment of Chronic Hepatitis B

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Medical Center

Oklahoma City, Oklahoma, 74104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hepatitis B positive by HBV DNA within 180 days.
  • Ages 18-70.
  • Men and non-pregnant women eligible.
  • Veteran's eligibility or appropriate health insurance.

Exclusion criteria

  • Use of any anti-HBV medicine within 30 days.
  • 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).
  • 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.
  • Severe cardiovascular disease (ejection fraction <20%)* or uncontrolled angina.
  • Severe pulmonary disease (FEV1 < 1.0).
  • Chronic renal insufficiency (creatinine clearance <50 ml/min.
  • HIV positive patients.

Treatment and study plan

simvastatin

Drug

daily doses for 14 days

Other names: Zocor

Tenofovir

Drug

Entecavir

Drug

Entecavir

Primary outcomes

  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 outcomes

  1. Alanine aminotransferase (ALT) reduction

    Time frame: 14 days

    ALT changes will be noted

Sponsors and collaborators

Lead sponsor

Bader, Ted, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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