Conditions: Sickle Cell Disease Iron Overload Hemolytic Anemia
Keywords: Sickle Cell Disease Iron Overload from Repeated Blood Transfusions Iron Overload Blood Transfusions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 212
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks. arm 2: Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.

Interventions: intervention 1: Deferasirox (ICL670) intervention 2: Deferoxamine (DFO)
Intervention descriptions: intervention 1: 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. intervention 2: Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.

Protocol document: