At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 65 enrolled
Drug / intervention
deferasirox:drug
Likely dose
Deferasirox 20-40 mg/kg/day orallyAI-extracted
Key inclusion· 3
- ✓Male or female patients with thalassemia major, sickle cell disease, low or intermediate-1 MDS, or other anemias with transfusional hemosiderosis
- ✓Patients on, starting, or resuming deferasirox treatment
- ✓Age ≥2 years
Key exclusion· 3
- ✕Serum creatinine above the upper limit of normal for age
- ✕ALT >2.5 times the upper limit of normal
- ✕High-risk intermediate-2 or high-risk MDS or acute leukemia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-arm, Open-label Study of the Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
In Brief
A Phase 4 clinical trial evaluating deferasirox: for Transfusional Hemosiderosis. Completed, enrolled 65 participants across 23 sites.
Detailed Summary
This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed. The study will began with a one month run-in phase, where all patients were instructed to take Deferasirox according to their physician's prescribing information.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransfusional Hemosiderosis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMay 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedFeb 18, 2009
Enrollment StartMay 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.4 years ago
Interventions
deferasirox:drug
Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.