Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients

Inclusion Criteria: * Patients of both genders aged from 1 month up to less than 18 years at the time of enrolment * Patients affected by any hereditary haemoglobinopathy requiring chronic transfusion therapy and chelation, including but not limited to thalassemia syndromes and sickle cell disease * Patients on current treatment with deferoxamine (DFO) or DFX or DFP in a chronic transfusion program receiving at least 150 mL/kg/year of packed red blood cells (corresponding approximately to 12 transfusions); * For patients naïve to chelation treatment: patients that have received at least 150 mL/kg of packed red blood cells (corresponding to approximately 12 transfusions) in a chronic transfusion program and with serum ferritin levels ≥ 800 ng/mL; * Until availability of results from the PK Study (Study DEEP-1, EudraCT n. 2012-000658-67) for patients aged from 1 month to less than 6 years: known intolerance or contraindication to DFO; * Written informed consent and patient's informed assent, relating to his/her comprehension abilities and level of maturity Exclusion Criteria: * Patients with intolerance or known contraindication to either DFP or DFX * Patients receiving DFX at a dose \> 40 mg/kg/day or DFP at a dose \> 100 mg/kg/day at screening * Platelet count \<100.000/mm3 during the run-in phase * Absolute neutrophils count \<1.500/mm3 during the run-in phase * Hb levels lower than 8g/dL during the run-in phase * Evidence of abnormal liver function * Iron overload from c…