Phase 4
Completed N=65
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
Transfusional Hemosiderosis
Source: ClinicalTrials.gov NCT00845871 ↗
Enrolled (actual)
65
Serious AEs
12.5%
Results posted
Jul 2021
Primary outcomePrimary: Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 — 10; 0; 0; 0 percentage of participants
◆ Published Evidence
Established
28citations · ~2 / year
The palatability and tolerability of deferasirox taken with different beverages or foods.
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.
Linked Publications
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The palatability and tolerability of deferasirox taken with different beverages or foods.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12 |
10; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation and Interruption |
39; 10; 6; 6; 6; 24 | — |
| SECONDARY Trough Plasma Concentration of Deferasirox at Week 8, Week 12 and Week 16 |
36.30; 66.95; 27.75; 20.15; 34.30; 54.50 | — |
| SECONDARY Change From Baseline in Serum Ferritin at Week 16 |
-198.1; 38.3; -593 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients with thalassemia major, sickle cell disease (SCD), low or intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and transfusional hemosiderosis.
- Patients who were on, starting, or resuming treatment with Exjade.
- Patients who were >2 years (i.e., 2 years of age or older).
Exclusion criteria
- Serum creatinine above the upper limit of normal (ULN) for age.
- Alanine aminotransferase (ALT) >2.5 times the ULN.-High risk intermediate-2 or high risk MDS or acute leukemia.
Data sourced from ClinicalTrials.gov (NCT00845871) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.