Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study

A 5-year Open Label, Non-comparative Extension to a Randomized, Open-label, Phase IIa Study to Evaluate Safety, Tolerability and the Effects on Liver Iron Concentration of Repeated Doses of 10 and 20 mg/kg/Day of Deferasirox in Comparison With 40 mg/kg/Day Deferoxamine in Patients With Transfusion-dependent Iron Overload

The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.

Inclusion Criteria:

• Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
• Patients currently participating in the food-effect sub-study, according to amendment 3.
• Ability to provide written informed consent prior to participation in this non-comparative extension study.
• Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
• Body weight of at least 35 kg.

Exclusion Criteria:

• Pregnant or breastfeeding patients.
• History of non-compliance to medical regimens and patients who are considered potentially unreliable.
• Proteinuria > 300 mg/L second void morning urine.
• Patients with serum creatinine above the upper limit normal.

Other protocol-defined inclusion/exclusion criteria may apply.