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IRCT20210830052346N1 IRCT 2021-11-09 Arak University of Medical Sciences Effect of Jadenu®️and Exjade®️on reducing liver and heart iron overload in Beta-Thalassemia Major and Intermedia A comparison study of the effects of Jadenu®️(Deferasirox) film-coated tablets and Exjade®️(Deferasirox) tablets for oral suspension on reducing liver and heart iron overload in patients with Beta-Thalassemia Major and Intermedia 2021-11-09 anticipated 66 Complete https://irct.ir/trial/58432 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method. 3 Beta Thalasemia major. Intervention 1: Intervention group: The group that receives Jadenu. Jadenu is part of the drug class deferasirox . 33 people are being treated with Deferasirox (Jadenu®) for 6 months. This drug will be given as a swallowable tablet at a dose of 20 mg / kg per day (once a day, daily for 6 months, by Novartis Pharma AG, Basel, Switzerland) to patients in this group. we start the treatment with the dose of 20 mg / kg and increase the dose to 40 mg / kg if needed. Intervention 2: Control group: The group that receives Exjade. Exjade is part of the drug class deferasirox. 33 people are being treated with Exjade for 6 months. It is given as a granule tablet at a dose of 20 mg / kg per day (once a day, daily for six months, by Novartis Pharma AG, Basel, Switzerland). Start treatment with a dose of 20 mg / kg and increase the dose to 40 mg / kg if needed. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the privacy of the information, patient information is kept confidential by the project manager
public Vahid falahati
No. 2, Sepahdar 4, Sevom Shaban st
Arak Iran (Islamic Republic of) 3815935139 +98 86 3277 5382 mahya.mobini@yahoo.com Arak University of Medical Sciences scientific Vahid Falahati
No. 2, Sepahdar 4, Sevom Shaban st
Arak Iran (Islamic Republic of) 3815935139 +98 86 3277 5382 mahya.mobini@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) 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 2 years 50 years Both 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 D56.1 Beta thalassemia Treatment - Drugs Treatment - Drugs Intervention group: The group that receives Jadenu. Jadenu is part of the drug class deferasirox . 33 people are being treated with Deferasirox (Jadenu®) for 6 months. This drug will be given as a swallowable tablet at a dose of 20 mg / kg per day (once a day, daily for 6 months, by Novartis Pharma AG, Basel, Switzerland) to patients in this group. we start the treatment with the dose of 20 mg / kg and increase the dose to 40 mg / kg if needed. Control group: The group that receives Exjade. Exjade is part of the drug class deferasirox. 33 people are being treated with Exjade for 6 months. It is given as a granule tablet at a dose of 20 mg / kg per day (once a day, daily for six months, by Novartis Pharma AG, Basel, Switzerland). Start treatment with a dose of 20 mg / kg and increase the dose to 40 mg / kg if needed. Cardiac iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2*MRI. Liver iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2*MRI. 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. Arak University of Medical Sciences Approved 2020-11-29 Ethics committee of Arak University of Medical Sciences No. 2, Sepahdar4, Sevom shaban st َArak Markazi Iran (Islamic Republic of)