At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 173 enrolled
Drug / intervention
Deferasirox dispersible tablet +1 moredrug
Likely dose
Deferasirox dispersible tablet 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 Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)
In Brief
A Phase 2 clinical trial evaluating Deferasirox dispersible tablet and Defearisox film-coated tablet for Chronic Iron Overload Due to Transfusion-dependant Anemias. Completed, enrolled 173 participants across 51 sites in 16 countries.
Detailed Summary
Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, France, Germany, Greece, Italy, Lebanon, Malaysia, Mexico, Russia, Saudi Arabia, Spain, Thailand, United Arab Emirates, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartJul 2014
Primary CompletionFeb 2016
TodayJul 2026
First PostedApr 29, 2014
Enrollment StartJul 8, 2014
Primary CompletionFeb 24, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.2 years ago
Interventions
Deferasirox dispersible tabletdrug
Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use.
Defearisox film-coated tabletdrug
Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.