Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
Liver Iron Overload
About this trial
This is an interventional treatment trial for Liver Iron Overload focused on measuring iron overload, iron chelation therapy, B-thalassemia
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Deferasirox
Deferasirox Crossover
Deferasirox group consists of all participants who were initially randomized to 10 and 20 mg/kg/day deferasirox orally daily in the main study and remained on the same treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative study
Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5mg/kg/day to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study