An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old

Inclusion Criteria: * Pediatric patients aged from 2 to less than 6 years old. * Patients with transfusion dependent β-thalassemia major. * Serum ferritin values ≥ 1000 ng/ml at screening. * Written informed consent must be obtained from the patient's legal guardian in accordance with local law and regulation prior to any screening procedures. Exclusion Criteria: * Non-transfusion-dependent thalassemia. * Systemic diseases which would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.) * Serum creatinine \> age adjusted ULN. * Significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥ 0.5mg/mg in a non-first void urine sample at screening. If UPCR is found to be ≥ 0.5 mg/mg the test can be repeated after 1 month. * ALT/AST \> 2.5xULN and total bilirubin \> 1×ULN. * Left ventricular ejection fraction \< 56% by echocardiography. * Patient has a known history of HIV seropositivity or history of active/treated hepatitis B or C (a test for screening is not required). * A history of clinically relevant ocular and/or auditory toxicity related to iron chelation therapy * Any surgical or medical conditions which will significantly alter the absorption, distribution, metabolism or excretion of the drug(e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection). * Other conditions which investigator deems potential harm to patients if participate the study.