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IRCT20251214068323N1 IRCT 2026-01-07 Mashhad University of Medical Sciences The effectiveness of drug combination in patients with beta-thalassemia major and severe iron overload A clinical trial comparing the effectiveness of deferoxamine–deferasirox, deferasirox–deferiprone, and deferoxamine–deferiprone combinations in patients with beta-thalassemia major and severe iron overload 2026-01-21 anticipated 105 Recruiting https://irct.ir/trial/88070 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The data collectors are blinded to group allocation and treatment method. 1-2 Beta-thalassemia major. Intervention 1: Intervention Group 1: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured by Novartis, widely used to reduce iron overload resulting from frequent blood transfusions.In addition, they will be treated with Deferoxamine (subcutaneous infusion, 30–50 mg/kg administered over 8–12 hours, at least five times per week, for a minimum of six months). Deferoxamine is an injectable iron chelator, typically delivered via a portable infusion pump, and is also produced by Novartis. This drug is specifically indicated for lowering iron burden in patients with thalassemia major. Intervention 2: Intervention Group 2: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured by Novartis, commonly prescribed to reduce iron overload in transfusion-dependent thalassemia patients.In addition, they will be treated with Deferiprone (oral tablet, 75–80 mg/kg per day, administered in three divided doses, for a minimum of six months). Deferiprone is another iron chelator, typically produced by Apotex, and is widely used in combination therapy to enhance iron removal from both plasma and intracellular compartments. Intervention 3: Intervention Group 3: Patients in this group will receive Deferoxamine at a dose of 30 to 50 mg/kg body weight, administered as a subcutaneous infusion over 8 to 12 hours, at least 5 times per week, for a minimum duration of 6 months. Deferoxamine is an injectable iron chelator, typically delivered via a portable infusion pump, and manufactured by Novartis. This drug is specifically indicated for reducing iron stores in patients with thalassemia major.In addition, patients will receive Deferiprone as an oral tablet at a dose of 75 to 80 mg/kg body weight per day, divided into 3 daily doses, for at least 6 months. Deferiprone is an oral iron chelator, commonly produced by Apotex, and is particularly used to enhance iron excretion from plasma and intracellular compartments. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Hamid Farhangi provides the data analysis to the applicants via email: farhangih@mums.ac.ir How to obtain: Applicants can send a message to the respondent’s email and will receive a reply within one week. Comments:
public Hamid Farhangi
Dr. Sheikh Pediatric Subspecialty Hospital, Dr. Sheikh Street, Tohid Square
Mashad Iran (Islamic Republic of) 9139963185 +98 51 3727 3943 farhangih@mums.ac.ir Mashhad University of Medical Sciences scientific Hamid Farhangi
Dr. Sheikh Pediatric Subspecialty Hospital, Dr. Sheikh Street, Tohid Square
Mashad Iran (Islamic Republic of) 9139963185 +98 51 3727 3943 farhangih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children with beta-thalassemia major and severe iron overload who have not achieved adequate iron control with monotherapy. Age above 5 years Severe iron overload defined as serum ferritin greater than 2500 ng/dl or severe/very severe iron overload reported in cardiac and hepatic MRI Absence of congenital heart disease Absence of chronic viral hepatitis infection Absence of heart failure 5 years 18 years Both Having chronic infectious diseases such as hepatitis Serum creatinine level increased by more than 25% above baseline Having proteinuria ALT level elevated more than five times the normal value Having study drugs allergies D56.1 Beta thalassaemia Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention Group 1: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured by Novartis, widely used to reduce iron overload resulting from frequent blood transfusions.In addition, they will be treated with Deferoxamine (subcutaneous infusion, 30–50 mg/kg administered over 8–12 hours, at least five times per week, for a minimum of six months). Deferoxamine is an injectable iron chelator, typically delivered via a portable infusion pump, and is also produced by Novartis. This drug is specifically indicated for lowering iron burden in patients with thalassemia major. Intervention Group 2: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured by Novartis, commonly prescribed to reduce iron overload in transfusion-dependent thalassemia patients.In addition, they will be treated with Deferiprone (oral tablet, 75–80 mg/kg per day, administered in three divided doses, for a minimum of six months). Deferiprone is another iron chelator, typically produced by Apotex, and is widely used in combination therapy to enhance iron removal from both plasma and intracellular compartments. Intervention Group 3: Patients in this group will receive Deferoxamine at a dose of 30 to 50 mg/kg body weight, administered as a subcutaneous infusion over 8 to 12 hours, at least 5 times per week, for a minimum duration of 6 months. Deferoxamine is an injectable iron chelator, typically delivered via a portable infusion pump, and manufactured by Novartis. This drug is specifically indicated for reducing iron stores in patients with thalassemia major.In addition, patients will receive Deferiprone as an oral tablet at a dose of 75 to 80 mg/kg body weight per day, divided into 3 daily doses, for at least 6 months. Deferiprone is an oral iron chelator, commonly produced by Apotex, and is particularly used to enhance iron excretion from plasma and intracellular compartments. Serum ferritin levels. Timepoint: 1, 2 and 3 months after intervention. Method of measurement: ELISA Ferritin Assay Kit. Hepatic iron concentration. Timepoint: 12 months after intervention. Method of measurement: Magnetic resonance imaging (MRI). Cardiac iron concentration. Timepoint: 12 months after intervention. Method of measurement: Magnetic resonance imaging (MRI). Mashhad University of Medical Sciences Approved 2025-11-04 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)