This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily
Novarts Investigative Site
Adelaide, Australia
Novarts Investigative Site
Brisbane, Australia
Novarts Investigative Site
Melbourne, Australia
Novarts Investigative Site
Sydney, Australia
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.
Time frame: 12 months
Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks.
Time frame: 12 months
Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup.
Time frame: 12 months
Changes in serum ferritin from baseline values to 53 weeks.
Time frame: 12 months
Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks
Time frame: 12 months
The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI
Time frame: 12 months
Changes in markers of iron load levels between baseline and 53 weeks.
Time frame: 12 months
The safety and tolerability of deferasirox therapy from baseline to 53 weeks
Time frame: 12 months
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