Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions

Inclusion Criteria: * Beta-thalassemia patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day * Liver iron content greater than 2 mg iron/g dw as measured by liver biopsy * Need for regular transfusions 8 or more times per year Exclusion Criteria: * Non-transfusional iron overload or transfusion-dependent anemias other than beta-thalassemia. * 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 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 * Diseases (cardiovascular, renal, hepatic, etc.)that would prevent the patient from undergoing any of the treatment options * Psychiatric or additive disorders that would prevent the patient from giving informed consent * History of drug or alcohol abuse within the 12 months prior to the study * Pregnant or breast feeding patients * Patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the s…