NCT00110617

Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients

A Randomized, Open-label, Multi-center, Phase II Study to Evaluate the Safety and Efficacy of Deferasirox (ICL670) 20 mg/kg/Day Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients With Iron Overload From Repeated Blood Transfusions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

Conditions

• Sickle Cell Disease
• Iron Overload
• Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	Deferasirox (ICL670)	Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
DRUG	Deferoxamine (DFO)	Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-05-11
• Last updated: 2011-05-26
• Results posted: 2011-05-02

Locations

59 sites across 2 countries: United States, Canada