At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 70 enrolled
Drug / intervention
Deferasirox +1 moredrug
Likely dose
Deferasirox 10 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 5-year Open Label, Non-comparative Extension to a Randomized, Open-label, Phase IIa Study to Evaluate Safety, Tolerability and the Effects on Liver Iron Concentration of Repeated Doses of 10 and 20 mg/kg/Day of Deferasirox in Comparison With 40 mg/kg/Day Deferoxamine in Patients With Transfusion-dependent Iron Overload
In Brief
A Phase 3 clinical trial evaluating Deferasirox for Liver Iron Overload. Completed, enrolled 70 participants across 4 sites.
Detailed Summary
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Iron Overload
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
Primary CompletionJan 2008
First PostedDec 2009
TodayJul 2026
First PostedDec 16, 2009
Enrollment StartFeb 1, 2003
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.5 years ago
Interventions
Deferasiroxdrug
10 mg/kg or 30 mg/kg orally daily
Deferasiroxdrug
5 mg/kg or 30 mg/kg orally daily