This study will evaluate the efficacy and safety of deferasirox in patients with MDS, thalassemia and rare anemia patients with transfusion iron overload.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Saint Petersburg, Russia
changes in ferritin level, compared to baseline, in patients with transfusion-induced iron overload treated with Exjade
Time frame: Baseline assessment is followed by monthly assessments for up to 1 year
changes in clinical manifestations of iron overload by means of echocardiogram (ECHO), electrocardiogram (ECG), routine laboratory assessments and physical examination
Time frame: Baseline assessment is followed by monthly assessments for up to 1 year.
changes in iron overload evidence on cardiac and liver magnetic resonance imaging (MRI) T2*, compared to baseline, in patients with transfusion-induced iron overload treated with Exjade
Time frame: at baseline and 1 at year (at the end of study).
Number of participants with adverse events. Safety is evaluated through the continuous monitoring and recording of adverse events, as well as though routine laboratory assessments and physical examination.
Time frame: From the start of study up to 1 year
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