Overview

Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Deferasirox
Iron
Criteria
Inclusion criteria:

- Male or female WITH haemoglobinopathy, Myelodysplastic Syndromes or other inherited or
acquired anaemia (e.g. MPD, Diamond-blackfan anaemia and other rare anaemias) patients
≥ 18 years and weighing >40kg.

- Lifetime minimum of > 20 units of packed red blood cell transfusions

- Normal or minimally abnormal cardiac function

Exclusion criteria:

- Contraindication to MRI scans

- High risk myelodysplastic syndromes patients and patients with other haematological
and non-haematological malignancies who are not expected to benefit from chelation
therapy due to the rapid progression of their disease

- Patients with uncontrolled high blood pressure

- An organ transplant less than 3 months previously

Other protocol-defined inclusion/exclusion criteria may apply.