NCT00673608CompletedPhase 4
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Deferasirox
Experimental
Intervention: deferasirox (Drug)
Outcomes
Primary Outcomes
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.
Time Frame: 12 months
Secondary Outcomes
- Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup.(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)
- Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks.(12 months)
Investigators
Study Sites (1)
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