Status:
COMPLETED
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Transfusional Hemosiderosis
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief Summary
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 Defera...
Detailed Description
Following the run-in phase, patients entered a three month, assessment phase. During the assessment phase, patients were given five general options for taking Deferasirox including with or without mea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00845871
Start Date
May 1 2009
End Date
August 1 2010
Last Update
July 20 2021
Active Locations (23)
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1
Children's Hospital and Research Center
Oakland, California, United States, 94609
2
Stanford University
Palo Alto, California, United States, 94304-1812
3
Bay Area Cancer Research Group
Pleasant Hill, California, United States, 94523
4
University of Colorado Denver, Colorado Sickle Cell Treatment and Research Center
Aurora, Colorado, United States, 80045