The purpose of this study is to test the safety and tolerability of SP-420 and it's efficacy in terms of lowering iron in subjects with Beta-thalassemia or other rare anemias who need regular blood transfusions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Self-administered by mouth
University of Toronto- University Health Network
Toronto, Canada
American University of Beirut Medical Center
Beirut, Lebanon
Siriraj Hospital
Bangkok, Thailand
Ege University Hospital
Izmir, Turkey (Türkiye)
The incidence of treatment-emergent Adverse Events (AEs)
Time frame: Week 24
The incidence of treatment-emergent Adverse Events (AEs)
Time frame: Week 52
Change in liver iron concentration (LIC) on R2-MRI from baseline
Time frame: Week 24
Change in liver iron concentration (LIC) on R2-MRI from baseline
Time frame: Week 52
Change in cardiac iron content (CIC) on T2*-MRI from baseline
Time frame: Week 24
Change in cardiac iron content (CIC) on T2*-MRI from baseline
Time frame: Week 52
Total iron removed by chelator (in mg) from baseline
Time frame: Week 24
Total iron removed by chelator (in mg) from baseline
Time frame: Week 52
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