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NCT00994773 · ClinicalTrials.gov registry record · Phase 1
Simvastatin for the Treatment of Chronic Hepatitis B
A Phase 1 study of Hepatitis B, sponsored by Bader, Ted, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT00994773 is a Phase 1 study of Hepatitis B that has completed, run by Bader, Ted, M.D.. The registered enrollment target is 32 participants, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00994773, a Phase 1 study of Hepatitis B, has completed, sponsored by Bader, Ted, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Simvastatin
- DRUG Tenofovir
- DRUG Entecavir
Study Locations (1)
Oklahoma
- VA Medical Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00994773
The ClinicalTrials.gov registry entry for NCT00994773 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower). The listed sponsor is Bader, Ted, M.D., which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis B appearing as the primary indexed condition, and to 3 interventions - of which Simvastatin is the first listed.
NCT00994773 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT00994773 about?
NCT00994773 is a clinical study titled "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. D...
What is the current status of trial NCT00994773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2009-12. Estimated completion is 2011-12.
What conditions does trial NCT00994773 study?
This clinical trial studies the following conditions: Hepatitis B.
What interventions are being tested in trial NCT00994773?
The interventions under investigation include: Simvastatin (DRUG), Tenofovir (DRUG), Entecavir (DRUG).
Who is sponsoring clinical trial NCT00994773?
This trial is sponsored by Bader, Ted, M.D., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00994773 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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