At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 134 enrolled
Drug / intervention
deferasiroxdrug
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.
An Open Label, Multi-center, Efficacy and Safety Study of Deferasirox in Iron Overloaded Patients With Non-transfusion Dependent Thalassemia
In Brief
A Phase 4 clinical trial evaluating deferasirox for Non-transfusion Dependent Thalassemia. Completed, enrolled 134 participants across 11 sites in 8 countries.
Detailed Summary
Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-transfusion Dependent Thalassemia
CountriesChina, Greece, Italy, Lebanon, Thailand, Tunisia, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartDec 2012
Primary CompletionJan 2015
Study CompletionJan 2019
TodayJul 2026
First PostedOct 18, 2012
Enrollment StartDec 6, 2012
Primary CompletionJan 3, 2015
Study CompletionJan 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.7 years ago
Interventions
deferasiroxdrug
Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing.