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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



Washington University School of Medicine Saint Louis, Missouri  63110
Stanford University Stanford, California  94305
New York Medical College Valhalla, New York  10595
Boston Medical Center Boston, Massachusetts  02118
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Schneider Children's Hospital New Hyde Park, New York  11042
Penn State Children's Hospital Hershey, Pennsylvania  17033-0850
University of Oklahoma Oklahoma City, Oklahoma  73190
Medical College of Georgia Augusta, Georgia  30912
Bay Area Cancer Research Group Concord, California  94520
New York Presbyterian Hospital New York, New York  10021
Tulane University Health Sciences Center New Orleans, Louisiana  70112
Yale University School Of Medicine New Haven, Connecticut  06520
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
The Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital of Boston Boston, Massachusetts  02115
Children's Hospital and Research Center Oakland, California  94609
University of Colorado Denver, Colorado Sickle Cell Treatment and Research Center Aurora, Colorado  80045
Children's Memorial Chicago, Illinois  60614
St Joseph Children's Hospital Paterson, New Jersey  07503
St Christopher's Hospital for Children Philadelphia, Pennsylvania  19134
Texas Children's Cancer Center and Hematology Services Houston, Texas  77030