* The primary objective is to assess the safety of Ferriprox oral solution for the treatment of iron overload in pediatric patients with transfusion-dependent anemia. * The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing iron overload in pediatric patients with transfusion-dependent anemia.
This will be a multi-centre, open label, single treatment, uncontrolled study. A total of 100 iron-overloaded pediatric patients with transfusion-dependent anemia will be enrolled in the study.Eligible patients will receive Ferriprox (deferiprone) oral solution, 100 mg/mL, at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided in three (3) doses, for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Ferriprox (deferiprone) oral solution will be given orally at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided into 3 doses, for 24 weeks.
Abo El Reish Hospital, Cairo University
Cairo, Egypt
Children Hospital, Ain Shams University
Cairo, Egypt
Cipto Mangunkusumo National Hospital
Jakarta, Indonesia
University of Malaya Medical Center
Kuala Lumpur, Malaysia
Occurrence of Adverse Events
Number of Adverse Events over 24 weeks
Time frame: 24 Weeks
Change in Serum Ferritin Concentration From Baseline.
The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study
Time frame: Baseline and 24 weeks
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