Simvastatin for the Treatment of Chronic Hepatitis B

August 15, 2012 updated by: Ted Bader, MD, Bader, Ted, M.D.

A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 74104
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simvastatin
Simvastatin orally
Drug: Simvastatin
daily doses for 14 days
Other Names:
  • Zocor
Experimental: Simvastatin and tenofovir
Simvastatin combined with tenofovir
Drug: Tenofovir
Drug: Simvastatin
daily doses for 14 days
Other Names:
  • Zocor
Experimental: Simvastatin and entecavir
Simvastatin combined with entecavir
Drug: Simvastatin
daily doses for 14 days
Other Names:
  • Zocor
Drug: Entecavir
Entecavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine aminotransferase (ALT) reduction
Time Frame: 14 days
ALT changes will be noted
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bader, Ted, M.D.

Investigators

  • Principal Investigator: Teddy Bader, M.D., University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 10, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV 14934
  • Simvastatin against HepB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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