drugset / Trial / NCT00631163

Efficacy and Safety of Deferasirox in Patients With Chronic Anemia and Transfusional Hemosiderosis

NCT00631163

Phase 2 Completed 102 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-10
Primary completion
2011-01
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 10 mg/kg Oral
Subject Deferasirox Unknown 20 mg/kg Oral
Subject Deferasirox Unknown 30 mg/kg Oral

Indications