Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Inclusion Criteria:

• Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion Criteria:

• Pregnant or breast feeding patients
• Patients being considered by the investigator potentially unreliable and/or a history of non-compliance