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

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ClinicalTrials.gov Identifier: NCT00673608
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Condition or disease Intervention/treatment Phase
Hemoglobinopathies Myelodysplastic Syndromes Other Inherited or Acquired Anaemia MPD Syndrome Diamond-Blackfan Anemia Other Rare Anaemias Transfusional Iron Overload Drug: deferasirox Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : November 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011


Arm Intervention/treatment
Experimental: Deferasirox Drug: deferasirox
Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily
Other Name: ICL670




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

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673608


Locations
Australia
Novarts Investigative Site
Adelaide, Australia
Novarts Investigative Site
Brisbane, Australia
Novarts Investigative Site
Melbourne, Australia
Novarts Investigative Site
Sydney, Australia
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00673608     History of Changes
Other Study ID Numbers: CICL670AAU01
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Haemoglobinopathies,
Myelodysplastic Syndromes,
Transfusional iron overload,
cardiac iron load

Additional relevant MeSH terms:
Syndrome
Anemia
Myelodysplastic Syndromes
Preleukemia
Iron Overload
Hemoglobinopathies
Anemia, Diamond-Blackfan
Disease
Pathologic Processes
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Iron Metabolism Disorders
Metabolic Diseases
Genetic Diseases, Inborn
Anemia, Hypoplastic, Congenital
Anemia, Aplastic
Red-Cell Aplasia, Pure
Iron
Deferasirox
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action