Thalassemia Major Clinical Trial
Official title:
Randomized Trial Comparing the Relative Efficacy of Deferiprone to That of Deferoxamine in Removing Excess Cardiac Iron in Thalassemia Major Patients
The purpose of this study is to determine whether deferiprone has superior efficacy in removing excess iron from the heart when compared with deferoxamine.
This study is a multi-center, randomized, open-label, controlled clinical trial. The study
population is participants with thalassemia major who are receiving regular chelation
therapy with deferoxamine. A total of sixty (60) participants will be enrolled among the
investigative sites.
The primary objective of this study is to determine whether deferiprone exhibits superior
efficacy in removing excess iron from the heart compared to that of the standard therapy,
deferoxamine.
The secondary objective is to evaluate the relative efficacy of deferiprone with respect to
that of deferoxamine as assessed by serum ferritin concentration and liver iron
concentration.
The primary efficacy measure in this study will be the participants' cardiac iron status, as
determined by heart MRI T2* assessments.
The secondary efficacy measure will be by serum ferritin concentration and liver iron
concentration. This will be measured by the Superconducting Quantum-Interference Device
(SQUID) BioSusceptometer.
The duration of treatment is 12 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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