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

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, renal, hepatic, etc.) that would prevent the patient from undergoing any of the treatment options
• •Psychiatric or addictive 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 start of the study
• •Patients who require concomitant therapy with hydroxyurea
• •Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function
• •Non-compliant or unreliable patients
• •Patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography
• •Patients unable to undergo SQUID examination