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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: Completed Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.

NCT00598572 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 20 participants
Start Date 2008-07
Est. Completion 2010-04
Phase Phase 1

What the finished NCT00598572 record still lists

NCT00598572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which Deferoxamine Mesylate is the first listed.

NCT00598572 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00598572's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00598572, the US trial registry maintained by the National Library of Medicine. NCT00598572 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.