Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

Completed · Phase 4

Conditions studied: Transfusional Hemosiderosis

In brief

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.

Key facts

Study ID

NCT00845871

Run by

Novartis Pharmaceuticals

People needed

65

Starts

2009-05-01

Expected to finish

2010-08-01

Last updated by the study team

2021-07-20

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Children's Hospital and Research Center — Oakland, California, United States
• Stanford University — Palo Alto, California, United States
• Bay Area Cancer Research Group — Pleasant Hill, California, United States
• University of Colorado Denver, Colorado Sickle Cell Treatment and Research Center — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Children's Memorial — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Children's Hospital of Boston — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• St Joseph Children's Hospital — Paterson, New Jersey, United States
• Schneider Children's Hospital — New Hyde Park, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Penn State Children's Hospital — Hershey, Pennsylvania, United States
• St Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• Texas Children's Cancer Center and Hematology Services — Houston, Texas, United States

Full record on ClinicalTrials.gov

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