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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferasirox | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deferasirox | Drug | Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks. | 12 months | |
| Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup. |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novarts Investigative Site | Adelaide | Australia | ||||
| Novarts Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27537786 | Derived | Ho PJ, Tay L, Teo J, Marlton P, Grigg A, St Pierre T, Brown G, Badcock CA, Traficante R, Gervasio OL, Bowden DK. Cardiac iron load and function in transfused patients treated with deferasirox (the MILE study). Eur J Haematol. 2017 Feb;98(2):97-105. doi: 10.1111/ejh.12793. Epub 2016 Sep 20. |
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| 12 months |
| Changes in serum ferritin from baseline values to 53 weeks. | 12 months |
| Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks | 12 months |
| The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI | 12 months |
| Changes in markers of iron load levels between baseline and 53 weeks. | 12 months |
| The safety and tolerability of deferasirox therapy from baseline to 53 weeks | 12 months |
| Brisbane |
| Australia |
| Novarts Investigative Site | Melbourne | Australia |
| Novarts Investigative Site | Sydney | Australia |
| ID | Term |
|---|---|
| D006453 | Hemoglobinopathies |
| D009190 | Myelodysplastic Syndromes |
| D005356 | Fibromyalgia |
| D029503 | Anemia, Diamond-Blackfan |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001855 | Bone Marrow Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D029502 | Anemia, Hypoplastic, Congenital |
| D000741 | Anemia, Aplastic |
| D000740 | Anemia |
| D012010 | Red-Cell Aplasia, Pure |
| D000080984 | Congenital Bone Marrow Failure Syndromes |
| D000080983 | Bone Marrow Failure Disorders |
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| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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