A Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Treated With Other Locally Approved Iron Chelators
A Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Treated With Other Locally Approved Iron Chelators
This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.
Inclusion Criteria:
Male or female patients greater than or equal to 2 years of age
Documented congenital disorder of red blood cells (e.g., β-thalassemia major, sickle cell anemia, diamond-blackfan anemia) requiring ongoing blood transfusions
Cannot be adequately treated with a locally approved iron chelator due to one of the following reasons:
History of at least 20 blood transfusions (equivalent to 100 mL/kg of packed red blood cells (PRBC])
Serum ferritin value greater than or equal to 1000 µg/L
Ability to comply with all study-related procedures, medications, and evaluations
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Savannah, Georgia 31403, United States
San Gavino Monreale- CA, Italy
Talassemie, Italy
Tau-Yuan County, Taiwan