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
2 Years
N/A
Both
Transfusional Hemosiderosis
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:
Interventional
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:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CICL670AUS32
NCT ID:
NCT00845871
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
Name | Location |
|---|---|
| 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 |
