CompletedPhase 4

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

United States65 participantsStarted 2009-05

Plain-language 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 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.

Who can participate

Age range2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Participants With Differing Palatability Scores at Week 8 and Week 12

Timeframe: Week 8 and Week 12

Trial details

NCT IDNCT00845871

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2021-05-11

View on ClinicalTrials.gov More Transfusional Hemosiderosis trials