Status:
COMPLETED
Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload
Lead Sponsor:
Novartis
Conditions:
Hemoglobinopathies
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00673608
Start Date
November 1 2007
End Date
September 1 2011
Last Update
February 23 2017
Active Locations (4)
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1
Novarts Investigative Site
Adelaide, Australia
2
Novarts Investigative Site
Brisbane, Australia
3
Novarts Investigative Site
Melbourne, Australia
4
Novarts Investigative Site
Sydney, Australia