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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

Phase 4
2 Years
Not Enrolling
Transfusional Hemosiderosis

Thank you

Trial Information

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

Following the run-in phase, patients will enter a three month, assessment phase. During the
assessment phase, patients will have five general options for taking Deferasirox including
with or without meals, crushed and added to a soft food or mixed in a liquid of choice.

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Palatability of Deferasirox as assessed by the Five-Point Facial Hedonic Scale

Outcome Time Frame:

at every week over 4 months (6 visits)

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

October 2010

Related Keywords:

  • Transfusional Hemosiderosis
  • Exjade
  • deferasirox
  • palatability
  • tolerability
  • food
  • iron overload
  • Serum Iron overload due to transfusions
  • Hemosiderosis



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