Clinical Trials Logo
  1. Home
  2. Iron Overload
  3. NCT00529152

Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients

Iron Overload Clinical Trial

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

Clinical Trial Summary

- 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.

Clinical Trial Description

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00529152
Study type Interventional
Source ApoPharma
Contact
Status Completed
Phase Phase 3
Start date August 2007
Completion date July 2008
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04423237 - Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients After HSCT
Completed NCT04614779 - Long-term Clinical Study of CN128 in Thalassemia Patients Phase 2
Withdrawn NCT03800446 - Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood N/A
Not yet recruiting NCT02833493 - Study of MRI Monitoring in Patients With Aplastic Anemia and Low or Int-1 Risk of MDS Complicated With Iron Overload N/A
Completed NCT02164253 - Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients Phase 2
Completed NCT00512226 - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00901199 - Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload Phase 2
Recruiting NCT00378469 - Study of the Effects of Muscular Activity on Iron Metabolism N/A
Completed NCT00117507 - Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients Phase 4
Completed NCT00138684 - Cytochrome P450 2E1 and Iron Overload Phase 2
Completed NCT03990181 - Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement N/A
Terminated NCT02274233 - Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia Phase 1
Active, not recruiting NCT01443195 - Iron Metabolism in Small Pre Term Newborns N/A
Completed NCT01546415 - Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia Phase 4
Completed NCT01572818 - Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients N/A
Not yet recruiting NCT00980421 - Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children Phase 3
Completed NCT01047098 - Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation N/A
Recruiting NCT05294471 - Fully Automated High-Throughput Quantitative MRI of the Liver
Completed NCT03591575 - Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children Phase 4
Active, not recruiting NCT00907283 - Ferrochelating Treatment in Patients Affected by Neurodegeneration With Brain Iron Accumulation (NBIA) Phase 2