Effect of Jadenu®?and Exjade®?on reducing liver and heart iron overload in Beta-Thalassemia Major and Intermedia

Phase 3

Recruiting

Conditions: Beta Thalasemia major.
Beta thalassemia
D56.1

Registration Number: IRCT20210830052346N1

Lead Sponsor: Arak University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 66

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2MRI.;Liver iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2MRI.;Aspartate aminotransferase(AST). Timepoint: At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu. Method of measurement: The patient's serum is separated by centrifugation and given to an autoanalyzer.;Alanine transaminase(ALT). Timepoint: At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu. Method of measurement: The patient's serum is separated by centrifugation and given to an autoanalyzer.

Secondary Outcome Measures