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IRCT20190106042262N1 IRCT 2019-03-02 Esfahan University of Medical Sciences Compare the efficacy of combination therapy of Deferasirox and Deferiprone in reducing iron load in patients with transfusion-Dependent β-Thalassemia. Compare the efficacy of combination Deferasirox and Deferiprone with Deferoxamine and Deferiprone in reducing heart and liver iron load in patients with transfusion-Dependent β-Thalassemia. 2018-02-19 anticipated 108 Complete https://irct.ir/trial/36668 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All samples encoded by a third person that does not participate in the research, and then by using a random digits table, patients were divided into two groups. 3 transfusion-Dependent β-Thalassemia. Intervention 1: Intervention group: for six month treated with Defrasirox (in this study we use Osveral 125mg, 250 and 500mg construction of Osvah Company of Iran) with 20-40 mg/kg daily and Deferiprone (construction of avicenna Company of Iran) with 15 mg/kg/dose in three dose. Intervention 2: Control group: for six month treated with Defroxamin(Vial 500mg) with 20-50 mg/kg daily that infusion with a pomp and Deferiprone (construction of avicenna Company of Iran) with 15 mg/kg/dose in three dose. Yes - There is a plan to make this available What will be shared: After the completion of the study, the protocol of study and the statistical analysis map, as well as all the data collected, including the individual data of the participants after unidentifiable people and main outcome will be presented in tables and diagrams in Result section of article.1 When: Immediately after the publication of result To whom: Everyone is able to access Conditions: For more study on patients with β-Thalassemia Where to obtain: Refer to email: Rezaali.fazeli6768@gmail.com How to obtain: After receiving a request email, documentation will be sent within one week Comments:
public Alireza Fazeli Varzaneh
Hezar jarib
Isfahan Iran (Islamic Republic of) 8375174647 +98 31 3527 6082 rezaali.fazeli6768@gmail.com Esfahan University of Medical Sciences scientific alireza Fazeli Varzaneh
Hezar jarib
Isfahan Iran (Islamic Republic of) 8375174647 +98 31 3527 6082 Rezaali.fazeli6768@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All Patients with transfusion-Dependent β-Thalassemia with ferritin more than 1000 All Patients with transfusion-Dependent β-Thalassemia who were not treated with combination iron chelators All Patients with transfusion-Dependent β-Thalassemia with heart and liver iron load All Patients with transfusion-Dependent β-Thalassemia with normal liver and renal function All Patients with transfusion-Dependent β-Thalassemia with age more than 10 years 10 years no limit Both Gastrointestinal problem before research D56.1 Beta thalassemia Treatment - Drugs Treatment - Drugs Intervention group: for six month treated with Defrasirox (in this study we use Osveral 125mg, 250 and 500mg construction of Osvah Company of Iran) with 20-40 mg/kg daily and Deferiprone (construction of avicenna Company of Iran) with 15 mg/kg/dose in three dose Control group: for six month treated with Defroxamin(Vial 500mg) with 20-50 mg/kg daily that infusion with a pomp and Deferiprone (construction of avicenna Company of Iran) with 15 mg/kg/dose in three dose Heart and liver iron concentration. Timepoint: At the start of research and six month later. Method of measurement: Magnetic resonance imaging T2*. Ferritin. Timepoint: At the start of research and third and sixth of study. Method of measurement: Serum ferritin level. Esfahan University of Medical Sciences Approved 2018-02-25 •Ethics committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)