NCT00901199

Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload

Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Elliott Vichinsky · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.

Detailed description

This was a phase two pilot clinical trial designed to evaluate the safety and efficacy of the combination of deferasirox and deferoxamine in transfusion dependent thalassemia with a range of systemic iron burden. The duration of combined therapy was 12 months. Changes in liver iron concentration, ferritin, myocardial iron, and serum creatinine was monitored.

Conditions

• Thalassemia
• Iron Overload

Interventions

Type	Name	Description
DRUG	Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)	All subjects will be given Deferasirox 20-30 mg/kg for 7 days per week. All subject will be given Deferoxamine 50 mg/kg for 3-7 days per week. The number of days for Deferoxamine will be determined by liver iron concentration at baseline.

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2009-05-13
• Last updated: 2021-08-12
• Results posted: 2021-08-12

Locations

1 site across 1 country: United States