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A randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in nontransfusion-dependent thalassemia patients with iron overload (THALASSA)

Update Il y a 5 ans
Reference: EUCTR2007-007000-15

Woman and Man

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Extract

Core: To compare the efficacy of two regimens of deferasirox administration (starting doses of 5 and 10 mg/kg/day) in patients with non-transfusion-dependent thalassemia based on change in LIC from baseline after one year of treatment compared to placebo treated patients. Extension: To evaluate the number of patients reaching LIC<5mg Fe/g dw and to evaluate the long-term safety of deferasirox administration in patients with non-transfusion-dependent thalassemia

Inclusion criteria

  • Chronic iron overload in patients with non-transfusion-dependent thalassemia

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