NCT02175225

Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial

Study of Deferoxamine Mesylate in Intracerebral Hemorrhage

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients with brain hemorrhage. The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Detailed description

This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial. Subjects will be randomized to either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a maximum daily dose of 6000 mg/day), or saline placebo, given by IV infusion for 3 consecutive days. Treatment will be initiated within 24 hours after ICH symptom onset. Randomization will control baseline imbalances associated with baseline ICH score, ICH onset-to-treatment time (OTT), ICH volume, baseline NIHSS score, and warfarin use. All subjects will be followed for 6 months and will receive standard of care therapy while participating in the study. Throughout the study, we will continue to assess the safety of DFO. At the conclusion of the study, the proportion of DFO-treated subjects with a good clinical outcome at 3 months (defined as modified Rankin Scale (mRS) score of 0-2) will be compared to the placebo proportion in a futility analysis to determine if it is futile to move DFO forward to Phase III efficacy evaluation.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Deferoxamine Mesylate
DRUG	Placebo (for Deferoxamine Mesylate)

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-02-10
• Completion: 2018-05-30
• First posted: 2014-06-26
• Last updated: 2019-05-30
• Results posted: 2019-05-30

Locations

28 sites across 2 countries: United States, Canada