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Study aim:
Comparison of the effect of Exjade® and Jadenu on the mean reduction of iron deposition in the heart and liver in patients with beta thalassemia major and intermedia
Design:
he present study is a randomized controlled clinical trial in which patients will be randomly divided into two equal groups (n = 33). One group will be given Exjade® and the other group will be given Jadenu.
Settings and conduct:
The present study is a randomized controlled clinical trial in which patients will be randomly divided into two equal groups (n = 33).
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
Age over 2 years old
patients with Beta-Thalassemia Major and Intermedia
Serum ferritin above 1000 μg / mL
Having informed consent to enter the study
No entry conditions
Having contraindication to Jadenu®️and Exjade®️
Patients with GFR ˂40 mL / min / 1.73 m^2
Patients with stunted growth
Patients with High-risk myelodysplastic syndromes (MDS)
malignant cancer
patients with platelet lower than 50x 10^9/L
Patients with prior knowledge of allergy to drugs of the defrazirox group
Patients with liver failure
Patients with gastrointestinal bleeding
Patients with renal failure
Using other iron chelators at the same time
age over 50 years old
Intervention groups:
The control group receives Exjade and the intervention group receives Jadenu.
Main outcome variables:
Cardiac iron load- Liver iron Load- Aspartate aminotransferase- Alanine transaminase-Existence of gastrointestinal side effects - level of satisfaction