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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: Completed Phase 1 study of Hepatitis B, sponsored by Bader, Ted, M.D..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Simvastatin will be given in doses of 5,10,20,and 40mg per day
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 |
What the finished NCT00994773 record still lists
NCT00994773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,628-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00994773's enrollment target sits among peer trials
32 24th of 32 higher than 8 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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