Know Cancer

or
forgot password

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
N/A
Not Enrolling
Both
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:

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 MedicineSaint Louis, Missouri  63110
Stanford UniversityStanford, California  94305
New York Medical CollegeValhalla, New York  10595
Boston Medical CenterBoston, Massachusetts  02118
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Schneider Children's HospitalNew Hyde Park, New York  11042
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
University of OklahomaOklahoma City, Oklahoma  73190
Medical College of GeorgiaAugusta, Georgia  30912
Bay Area Cancer Research GroupConcord, California  94520
New York Presbyterian HospitalNew York, New York  10021
Tulane University Health Sciences CenterNew Orleans, Louisiana  70112
Yale University School Of MedicineNew Haven, Connecticut  06520
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital of BostonBoston, Massachusetts  02115
Children's Hospital and Research CenterOakland, California  94609
University of Colorado Denver, Colorado Sickle Cell Treatment and Research CenterAurora, Colorado  80045
Children's MemorialChicago, Illinois  60614
St Joseph Children's HospitalPaterson, New Jersey  07503
St Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134
Texas Children's Cancer Center and Hematology ServicesHouston, Texas  77030