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Completed

NCT Number: NCT00673608

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

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients

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Key information

Conditions

Hemoglobinopathies Anemia Anemia, Aplastic Anemia, Diamond-Blackfan Anemia, Hypoplastic, Congenital Bone Marrow Diseases Bone Marrow Failure Disorders Congenital Bone Marrow Failure Syndromes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diamond-Blackfan Anemia Fibromyalgia Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases MPD Syndrome Muscular Diseases Musculoskeletal Diseases Myelodysplastic Syndromes Nervous System Diseases Neuromuscular Diseases Other Inherited or Acquired Anaemia Other Rare Anaemias Red-Cell Aplasia, Pure Rheumatic Diseases Transfusional Iron Overload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novarts Investigative Site, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deferasirox

Drug

Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily

Other names: ICL670

Primary outcomes

  1. Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.

    Time frame: 12 months

Secondary outcomes

  1. Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks.

    Time frame: 12 months

  2. 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

  3. Changes in serum ferritin from baseline values to 53 weeks.

    Time frame: 12 months

  4. Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks

    Time frame: 12 months

  5. The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI

    Time frame: 12 months

  6. Changes in markers of iron load levels between baseline and 53 weeks.

    Time frame: 12 months

  7. The safety and tolerability of deferasirox therapy from baseline to 53 weeks

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 7, 2008
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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