Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 24-Week, Open Label, Uncontrolled Study of the Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients With Transfusion-Dependent Anemia|
- Occurrence of Adverse Events [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
- Change in Serum Ferritin Concentration From Baseline. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Ferriprox Oral Solution single treatment
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.
Other Name: Ferriprox Oral Solution
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.
|Children Hospital, Ain Shams University|
|Abo El Reish Hospital, Cairo University|
|Cipto Mangunkusumo National Hospital|
|Jakarta, Indonesia, 10010|
|University of Malaya Medical Center|
|Kuala Lumpur, Malaysia, 50603|
|Principal Investigator:||Prof. Mohsen S El Alfy, MD||Children Hospital, Ain Shams University, Cairo, Egypt|