Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage "DFO In ICH"

Completed

Phase 1 Results N/A

Trial Description

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.

Conditions

Interventions

  • Deferoxamine Mesylate Drug
    Intervention Desc: Various dose-regimens ranging from 7 mg/kg to 125 mg/kg (with a maximum allowable total daily dose of 6000 mg at any of the tested dose tiers, regardless of patient's weight), administered daily by IV infusion for three consecutive days.
    ARM 1: Kind: Experimental
    Label: 1
    Description: All participants will receive various dose-regimens of the study drug. Each dose cohort will consist of at least 3 subjects.

Trial Design

  • Masking: Open Label
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Patient Involvement

All participants will receive various dose-regimens of the study drug. Each dose cohort will consist of at least 3 subjects. Drug: Deferoxamine Mesylate Various dose-regimens ranging from 7 mg/kg to 125 mg/kg (with a maximum allowable total daily dose of 6000 mg at any of the tested dose tiers, regardless of subject's weight), administered daily by IV infusion for three consecutive days. Subjects will undergo repeated clinical assessments up to 90 days, and CT imaging pre- and post-drug administration.

Outcomes

Type Measure Time Frame Safety Issue
Primary The safety and tolerability outcome is the occurrence of a dose limiting toxicity [Time Frame: First 7 days of hospitalization or diacharge, whichever occurs earlier] The pre-defined dose-limisting toxicities are: 1. Anaphylaxis (at any time point during DFO infusion) 2. Hypotension requiring medical treatment at any time point during DFO infusion that cannot be explained by other causes. 3. Worsening neurological status, that cannot be explained by other causes, compared to baseline values occurring at any point during DFO infusion 4. Mortality. 5. Any adverse event prolonging hospital stay, resulting in emergent medical treatment, or resulting in death.
Primary Dose-limiting toxicities First 7 days of hospitalization or diacharge, whichever occurs earlier Yes

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