At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 enrolled
Drug / intervention
Deferasiroxdrug
Likely dose
Not stated in 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.
Open Label, Multicenter Study to Evaluate Safety/Tolerability and Efficacy of Deferasirox (ICL670) in Myelodysplastic Syndrome Patients With Chronic Transfusional Hemosiderosis.
Gruppo Italiano Malattie EMatologiche dell'Adulto·interventional·Posted May 4, 2007·Updated Nov 22, 2016
In Brief
A Phase 3 clinical trial evaluating Deferasirox for Myelodysplastic Syndromes and Hemosiderosis. Completed, enrolled 158 participants across 17 sites.
Detailed Summary
Open label, single arm study on Deferasirox treatment in MDS patients with chronic transfusional hemosiderosis. Patients receive daily oral dosis of Deferasirox in order to eliminate the quantity of iron administered during transfusions and, if needed, to reduce the overload of already present iron. After an screening phase in which patients are evaluated according to eligibility criteria, a one year treatment phase foresees monthly visits to evaluate safety and efficacy signs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes, Hemosiderosis
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJun 2007
Primary CompletionMar 2010
Study CompletionNov 2013
TodayJul 2026
First PostedMay 4, 2007
Enrollment StartJun 1, 2007
Primary CompletionMar 1, 2010
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.2 years ago
Interventions
Deferasiroxdrug