Transfusional Iron Overload in ß-thalassemia Clinical Trial
Official title:
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator
was conducted to investigate the efficacy of deferasirox in regularly transfused patients
with β-thalassemia 2 years of age and older. Patients who successfully completed this main
trial may continue in this extension trial to receive chelation therapy with deferasirox for
an additional 4 years.
The objective of this study is to assess the efficacy and long-term safety of deferasirox in
regularly transfused patients with β-thalassemia 2 years of age and older.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment