Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

Inclusion Criteria:

- Male and female patients aged ≥ 10 years

- Patients with transfusion-dependent thalassemia and iron overload, requiring
deferasirox DT at doses of ≥ 30 mg/kg/day as per the investigator's decision OR
Patients with very low, low or intermediate (int) risk myelodysplastic syndrome (MDS)
and iron overload, requiring deferasirox DT at doses of ≥ 20 mg/kg/day as per the
investigator's decision.

- History of transfusion of at least 20 PRBC units and anticipated to be transfused
with at least 8 units of PRBCs annually during the study

- Serum ferritin > 1000 ng/mL, measured at screening Visit 1 and screening Visit 2 (the
mean value will be used for eligibility criteria).

Exclusion Criteria:

- Creatinine clearance below the contraindication limit in the locally approved
prescribing information. Creatinine clearance will be estimated from serum creatinine
at screening Visit 1 and screening Visit 2 and the mean value will be used for
eligibility criteria.

- Serum creatinine > 1.5 xULN at screening measured at screening Visit 1 and screening
Visit 2 (the mean value will be used for eligibility criteria).

- ALT (SGPT) > 5xULN, unless LIC confirmed as >10 mg Fe/dw within 6 months prior to
screening visit 1.

- Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5
mg/mg in a non-first void urine sample at screening Visit 1 or screening Visit 2.

- Patients with significant impaired gastrointestinal (GI) function or GI disease that
may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel
resection).

- Liver disease with severity of Child-Pugh Class B or C