Conditions: Transfusional Iron Overload in β-thalassemia
Keywords: β-thalassemia iron overload deferasirox
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 506
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight.

Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: Tablets taken orally once a day.

Protocol document: