Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT00529152|
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : August 12, 2009
Last Update Posted : September 2, 2009
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Iron Overload||Drug: Deferiprone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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
- Occurrence of Adverse Events [ Time Frame: 24 Weeks ]Number of Adverse Events over 24 weeks
- Change in Serum Ferritin Concentration From Baseline. [ Time Frame: Baseline and 24 weeks ]The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529152
|Abo El Reish Hospital, Cairo University|
|Children Hospital, Ain Shams 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|