Transfusional Iron Overload Clinical Trial
Official title:
A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions
This is a clinical research study in patients who have iron overload in the heart due to
chronic blood transfusions.
The study will have 2 treatment groups and will compare the safety and efficacy of chelation
therapy with a medicine called deferasirox (ICL670) with another medicine called
deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best
for treating iron overload in the heart.
Patients will be treated for 12 months (core study phase). Patients who complete the core
study phase will be offered to continue their study treatment in a 12 months extension
phase. During the core and extension, the effects of treatment on iron overload in the heart
and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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