At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
Deferipronedrug
Likely dose
Deferiprone 75 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Deferiprone for Iron Overload. Completed, enrolled 100 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Overload
CountriesEgypt, Indonesia, Malaysia
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedSep 2007
Primary CompletionJul 2008
TodayJul 2026
First PostedSep 14, 2007
Enrollment StartAug 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.8 years ago
Interventions
Deferipronedrug
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.