A study of the Palatability and Tolerability of Exjade Taken with Meals, with Different Liquids or Crushed and Added to Food

• Conditions: transfusional hemosiderosis; MedDRA version: 14.0Level: LLTClassification code 10065974Term: Chronic iron overloadSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-004217-17-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1.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.
2.Patients who were on, starting, or resuming treatment with Exjade.
3.Patients who were >2 years (i.e., 2 years of age or older).

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1.Serum creatinine above the upper limit of normal (ULN) for age.
2.Alanine aminotransferase (ALT) >2.5 times the ULN.
3.High risk intermediate-2 or high risk MDS or acute leukemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified