Trial Search Results

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

This single-arm, open-label, multi-center study will enroll 60 patients from approximately 20 centers. All patients who meet study criteria and are currently taking, beginning or resuming treatment with Deferasirox will be allowed. The study will begin with a one month run-in phase, where all patients will be instructed to take Deferasirox according to their physician's current prescribing information.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Intervention(s):

  • Drug: deferasirox:

Phase:

Phase 4

Eligibility


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.

Ages Eligible for Study

2 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting