Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT01254227
Eligibility Criteria:
Inclusion Criteria:
* Patients with β-thalassemia major or Diamond-Blackfan anemia (DBA) or congenital sideroblastic anemia on chronic transfusion therapy
* Myocardial T2\* value that is ≥ 5 and \< 10 ms
* Left ventricular ejection fraction (LVEF) ≥ 56% as determined by Magnetic resonance imaging (MRI)
* Liver Iron Concentration (LIC) ≥ 7 mg Fe /g dw as determined by R2 MRI.
* Lifetime history of at least 50 units of red blood cell transfusions, and must be receiving at least ≥ 8 units/yr of red blood cell transfusions
* Serum ferritin ≥ 1000 ng/mL
Exclusion Criteria:
* Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)
* Patients unable to undergo study assessments including MRI
* Patients with serum creatinine greater than Upper limit of normal ULN)range or with significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥1.0 mg/mg in a non-first void urine sample at baseline.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT01254227
Study Brief:
Protocol Section:
NCT01254227