Hepatitis BPhase 1NCT00994773
Simvastatin for the Treatment of Chronic Hepatitis B
A Phase 1 study testing Simvastatin, Tenofovir and Entecavir in people with Hepatitis B, run by Bader, Ted, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Simvastatin, Tenofovir and Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatitis B
- Being tested
- Simvastatin, Tenofovir, Entecavir
- Keywords
- Hepatitis B, simvastatin, HBV DNA
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
daily doses for 14 days
TenofovirDrug
EntecavirDrug
Entecavir
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Simvastatin orally Receives: Drug: Simvastatin |
| Simvastatin and tenofovir | Experimental | Simvastatin combined with tenofovir Receives: Drug: Simvastatin; Drug: Tenofovir |
| Simvastatin and entecavir | Experimental | Simvastatin combined with entecavir Receives: Drug: Simvastatin; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of HBV DNA by one log.
Simvastatin will be given in doses of 5,10,20,and 40mg per day
Measured: 14 days
Secondary outcomes (1)
Alanine aminotransferase (ALT) reduction
ALT changes will be noted
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bader, Ted, M.D.
- Responsible party
- Principal investigator, Ted Bader, MD, Bader, Ted, M.D.
- Investigators
- Teddy Bader, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994773
- Sponsor's protocol ID
- HBV 14934
- Other IDs
- Simvastatin against HepB
- Status last verified
- Aug 2012
- First submitted
- 10 Oct 2009
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00994773
- Acronym / sponsor ID
- HBV 14934
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, simvastatin, HBV DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bader, Ted, M.D.
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin orally |
| Simvastatin and tenofovir | Experimental | Drug: Simvastatin, Drug: TenofovirSimvastatin combined with tenofovir |
| Simvastatin and entecavir | Experimental | Drug: Simvastatin, Drug: EntecavirSimvastatin combined with entecavir |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinAlso: Zocordaily doses for 14 days | Drug | Simvastatin, Simvastatin and entecavir, Simvastatin and tenofovir |
| Tenofovir | Drug | Simvastatin and tenofovir |
| EntecavirEntecavir | Drug | Simvastatin and entecavir |
Primary outcome
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
1 secondary outcome
Alanine aminotransferase (ALT) reduction
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teddy Bader, M.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simvastatin, Tenofovir and Entecavir in people with Hepatitis B, run by Bader, Ted, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of HBV DNA by one log. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.