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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Novartis Investigative Site
Cagliari, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Torino, Italy
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment
Time frame: at 3, 4, 5 years
Change in liver iron content measured by SQUID, at 3, 4, and 5 years
Time frame: at 3, 4, 5 years
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