Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions

Inclusion Criteria: * Age greater than or equal to 2 years * Sickle cell disease patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day * Serum ferritin greater than 1000 mg/ml * Liver iron content greater than 2 mg iron/g dw assessed by means of superconducting quantum interference device (SQUID) for patients who receive simple transfusions and greater than 5 mg iron/ g dw for patients who receive exchange transfusions or who have a history of intermittent blood transfusion. * Regular transfusion aimed at maintaining % Hb A above 50% or a previous history of simple transfusion being the recipient of at least 20 units of packed red blood cells. Exclusion Criteria: * Chronic anemias other than sickle cell disease * Documented toxicity to deferoxamine * Elevated liver enzymes in the year preceeding enrollment * Active hepatitis B or hepatitis C * HIV seropositivity * Elevated serum creatinine or significant proteinuria * History of nephrotic syndrome * Uncontrolled systemic hypertension * Fever and other signs/symptoms of infection within 10 days prior to the start of the study * Presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation * Second or third degree AV block, clinically relevant Q-T interval prolongation, or patients requiring digoxin or other drugs that prolong the Q-T interval (other than beta-adrenergic receptor blocking agents). * Diseases (cardiovascular…