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NCT00598572 · ClinicalTrials.gov registry record · Phase 1
Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage
A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00598572 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT00598572, a Phase 1 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Animal studies show that the breakdown of blood results in iron accumulation in the brain after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients. Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to remove excessive iron from the body, and has been shown to provide some benefit in animal studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with DFO in patients with ICH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with DFO can improve the outcome of patients with ICH. Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy of DFO in improving outcome after ICH. We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients with ICH; and that treatment with DFO will improve patients' outcome. The results can potentially bring into account new means to improve the outcome of patients with ICH. ICH is a frequent cause of disability and death. A successful study demonstrating the efficacy of iron-modifying therapy would be of considerable public health significance.
Interventions
- DRUG Deferoxamine Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-07 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00598572
The ClinicalTrials.gov registry entry for NCT00598572 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Deferoxamine Mesylate is the first listed.
NCT00598572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00598572 about?
NCT00598572 is a clinical study titled "Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage". Animal studies show that the breakdown of blood results in iron accumulation in the brain after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients. Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to remove excessive iron from t...
What is the current status of trial NCT00598572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-07. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00598572?
The interventions under investigation include: Deferoxamine Mesylate (DRUG).
Who is sponsoring clinical trial NCT00598572?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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