Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
|ClinicalTrials.gov Identifier: NCT02175225|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Last Update Posted : January 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Deferoxamine Mesylate Drug: Placebo (for Deferoxamine Mesylate)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study of Deferoxamine Mesylate in Intracerebral Hemorrhage|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Deferoxamine Mesylate
Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days
|Drug: Deferoxamine Mesylate|
Placebo Comparator: Normal Saline
Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days
|Drug: Placebo (for Deferoxamine Mesylate)|
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.
- Adverse Events [ Time Frame: 3 months ]
All adverse events (serious and non-serious) will be assessed until day-7 or discharge (whichever is earlier), and serious adverse events (SAEs) until day-90.
Safety endpoints will include all DFO-related adverse events until day-7 or discharge (whichever is earlier), and SAEs through day-90.
Mortality (all cause and ICH-related) will be assessed through day 180.
- Proportion of patients with mRS score 0-3 [ Time Frame: 3 months ]
Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days.
Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability.
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 6 months ]Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-3 [ Time Frame: 6 months ]Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days
- Proportion of subjects with good outcome in the early vs. delayed treatment time windows [ Time Frame: 90 and 180 days ]Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows.
- Ordinal distribution of scores on mRS [ Time Frame: 90 and 180 days ]The overall ordinal distribution of scores on mRS at 3 and 6 months in DFO- and placebo-treated subjects will be determined.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175225
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|Study Chair:||Magdy Selim, MD, PhD||Beth Israel Deaconess Medical Center|