Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study

Core Inclusion Criteria: * Male or female aged ≥ 10 years with non-transfusion dependent syndromes, not requiring transfusion within 6 months prior to study start. Note: there was a local country amendment for Greece only to change the age specific inclusion criteria to ≥ 18 years old * Liver iron concentration ≥ 5 mg/g dry weight measured by Magnetic resonance imaging (MRI) before study start * Serum ferritin \>300 ng/mL at screening Core Exclusion Criteria: * Hemoglobin S (HbS)-variants of thalassemia syndromes * Anticipated regular transfusion program during the study. Patients having a sporadic transfusion (e.g. in case of infection) throughout the study course will not be excluded * Any blood transfusion 6 months prior to study start * Creatinine clearance ≤ 60 mL/min at screening * Serum creatinine above the upper limit of normal at both screening visits * Significant proteinuria as indicated by a urine protein/urine creatinine ratio \> 1.0 mg/mg * Alanine aminotransferase (ALT) of \> 5 x the upper limit of normal at both screening visits * Concomitant therapy with hydroxyurea, erythropoietin, butyrate * History of deferasirox treatment * Pediatric patients: a patient's weight of below 20 kg Extension Inclusion Criteria: * Patients who completed the core CICL670A2209 clinical trial * Written informed consent obtained prior entry to one year extension study CICL670A2209 Extension Exclusion Criteria: * Patients with a continuous increase in serum creatinine ≥ 33% a…