NCT00600938

Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload

A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart. Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.

Conditions

• Transfusional Iron Overload
• Transfusional Hemosiderosis

Interventions

Type	Name	Description
DRUG	Core Study: Deferasirox	20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
DRUG	Core Study: Deferoxamine	50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
DRUG	Extension: deferoxamine to deferasirox	40 mg/kg deferasirox once daily administered 30 minutes before taking food.
DRUG	Extension: deferasirox to deferoxamine	DFO at a target range of 50 mg/kg/day to 60 mg/kg/day via subcutaneous (sc) infusion lasting a period of 8 to 12 hrs administered for 5 to 7 days per week,
DRUG	Deferasirox
DRUG	Deferoxamine

Timeline

• Start date: 2007-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-01-25
• Last updated: 2014-08-27
• Results posted: 2014-08-27

Locations

21 sites across 11 countries: Canada, China, Cyprus, Egypt, Italy, Lebanon, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom