Conditions: Chronic Anemia Transfusional Hemosiderosis
Keywords: Iron Overload, Chelation, MDS, Chronic Anemia, Deferasirox, Transfusional hemosiderosis,
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 102
Healthy volunteers: no

Brief summary:
The overall purpose of this trial is to further evaluate the efficacy and safety of deferasirox, dosed initially according to the transfusional iron intake, in patients with transfusion dependant anemia related to disorders other than β-thalassemia and sickle cell disease.

During the study, the dose will be adjusted based on serum Ferritin.The overall purpose of the extension is to allow further treatment of patients who have already completed the core study, and to enable collection of long term efficacy and safety data. Patients will continue to receive Deferasirox at the dose they received at the end of the core study.

Detailed description:

Arms:
arm 1: Participants received initial dose of 20 milligrams per kilogram (mg/kg) Deferasirox tablets was administered orally once daily (OD) based on the Participants body weight. The dose of Deferasirox was adjusted to either 10 mg/kg or 30 mg/kg based on the volumes of blood transfusions being administered.

Interventions: intervention 1: Deferasirox (ICL670)
Intervention descriptions: intervention 1: The recommended initial daily dose of Deferasirox is 20 mg/kg body weight.

Protocol document: