NCT00631163

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

A Multi-Center, Open-label, Non Comparative, Phase II Trial on Efficacy and Safety of ICL670 Given for 1 Year With Dose Adjustments Based on Serum Ferritin in Patients With Chronic Anemia and Transfusional Hemosiderosis Including an Additional 1 Year Extension.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Anemia
• Transfusional Hemosiderosis

Interventions

Type	Name	Description
DRUG	Deferasirox (ICL670)	The recommended initial daily dose of Deferasirox is 20 mg/kg body weight.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-01-01
• Completion: 2012-02-01
• First posted: 2008-03-07
• Last updated: 2021-06-29
• Results posted: 2021-06-29

Locations

31 sites across 5 countries: Japan, Poland, Singapore, Spain, Turkey (Türkiye)