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.