EUCTR2016-000246-62-Outside-EU/EEA
Active, Not Recruiting
Phase 1
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)
ConditionsMedDRA version: 19.0Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsExjade
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 19.0Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 100000004864
- Sponsor
- ovartis
- Enrollment
- 53
- Status
- Active, Not Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 41
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 7
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.
Outcomes
Primary Outcomes
Not specified
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