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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00673608
• Date of registration: 05/05/2008
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload
• Scientific title: A Study of Magnetic Resonance Imaging Assessment of Cardiac and Liver Iron Load in Patients With Haemoglobinopathies, Myelodysplastic Syndromes (MDS) or Other Anaemias Treated With Exjade® (Deferasirox) (The MILE Study)
• Date of first enrolment: November 2007
• Target sample size: 118
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00673608
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmeceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Other Inherited or Acquired Anaemia

Other Rare Anaemias

Hemoglobinopathies

Myelodysplastic Syndromes

Transfusional Iron Overload

MPD Syndrome

Diamond-Blackfan Anemia

Intervention(s)

Drug: deferasirox

Primary Outcome(s)

Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks. [Time Frame: 12 months]

Secondary Outcome(s)

Changes in serum ferritin from baseline values to 53 weeks. [Time Frame: 12 months]

The safety and tolerability of deferasirox therapy from baseline to 53 weeks [Time Frame: 12 months]

Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks. [Time Frame: 12 months]

Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup. [Time Frame: 12 months]

Changes in markers of iron load levels between baseline and 53 weeks. [Time Frame: 12 months]

The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI [Time Frame: 12 months]

Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks [Time Frame: 12 months]

Secondary ID(s)

CICL670AAU01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors