Simvastatin for the Treatment of Chronic Hepatitis B

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994773
• Other study ID #: HBV 14934
• Secondary ID: Simvastatin agai
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2009
• Last updated: August 15, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Bader, Ted, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Simvastatin
daily doses for 14 days
• Tenofovir

• Entecavir
Entecavir

Locations

Country	Name	City	State
United States	VA Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bader, Ted, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of HBV DNA by one log.	Simvastatin will be given in doses of 5,10,20,and 40mg per day	14 days	No
Secondary	Alanine aminotransferase (ALT) reduction	ALT changes will be noted	14 days	Yes