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

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
• •Patients with a continuous increase in serum creatinine ≥ 33% above the baseline value and \> ULN who did not improve after drug interruption or dose reduction in the core study
• •Patients with a continuous increase in ALT greater than 2 times the baseline value and \> 5 times ULN who did not improve after drug interruption or dose reduction in the core study
• •Patients with progressive proteinuria, as assessed by the investigator, who did not improve after drug interruption or dose reduction in the core study
• •Significant medical condition interfering with the ability to partake in this study (e.g.systemic uncontrolled hypertension, unstable cardiac disease not controlled by standard medical therapy, systemic disease (cardiovascular, renal, hepatic, etc.)