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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00673608
First received: May 5, 2008
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Haemoglobinopathies,
Myelodysplastic Syndromes,
Other Inherited or Acquired Anaemia (e.g. MPD, Diamond-blackfan Anaemia and Other Rare Anaemias),
Transfusional Iron Overload
 Drug: deferasirox
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Drug Information available for: Deferasirox
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in serum ferritin from baseline values to 53 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in markers of iron load levels between baseline and 53 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The safety and tolerability of deferasirox therapy from baseline to 53 weeks [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: November 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deferasirox Drug: deferasirox
Deferasirox up to 40mg/kg/day, PO, Dispersible tablets, taken once daily
Other Name: ICL670

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00673608     History of Changes
Other Study ID Numbers: CICL670AAU01
Study First Received: May 5, 2008
Last Updated: November 28, 2012
Health Authority: Australia: Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013