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

Novartis

Status and phase

Completed

Phase 4

Conditions

Transfusional Hemosiderosis

Treatments

Drug: deferasirox:

Study type

Interventional

Funder types

Industry

Identifiers

NCT00845871

2011-004217-17 (EudraCT Number)

CICL670AUS32

Details and patient eligibility

About

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.

Full 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 meals, crushed and added to a soft food or mixed in a liquid of choice.

Enrollment

65 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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.