At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 225 enrolled
Drug / intervention
Deferasirox +1 moredrug
Likely dose
Deferasirox 125 mgfrom 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 Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload
In Brief
A Phase 2 clinical trial evaluating Deferasirox and Placebo for Myelodysplastic Syndromes. Completed, enrolled 225 participants across 71 sites in 16 countries.
Detailed Summary
This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was conducted in 17 countries, started in 2010 and ended in 2018.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesAustralia, Bulgaria, Canada, China, Denmark, Greece, Hong Kong, Italy, Malaysia, Mexico, New Zealand, Russia, Switzerland, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartMar 2010
Primary CompletionFeb 2018
TodayJul 2026
First PostedJul 16, 2009
Enrollment StartMar 22, 2010
Primary CompletionFeb 27, 2018
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 17.0 years ago
Interventions
Deferasiroxdrug
Deferasirox provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
Placebodrug
Inactive ingredients used as a placebo comparator, provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use