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Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia

RecruitingNAAges any - anyAllRiphah International University
NCT07673302 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to determine the safety and therapeutic effect of HbF inducers (combination therapy: thalidomide and hydroxyurea) on beta thalassemia patients. The main objectives of this study are: * To determine the therapeutic efficacy of HbF inducers (combination therapy: thalidomide and hydroxyurea) on hemoglobin level and blood transfusion in beta thalassemia patients. * To determine the safety of HbF inducers (combination therapy: thalidomide and hydroxyurea) in beta thalassemia patients * To determine effect of HbF inducers (combination therapy: thalidomide and hydroxyurea) on quality of life of beta thalassemia patients

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Confirmed diagnosis of Beta thalassemia Major (BTM) ascertained by Hemoglobin Electrophoresis or HPLC report performed pre-transfusion or genetic testing profile (comprising PCR or HBB gene sequencing) suggestive of ฮฒ-thalassemia syndrome. * All ages and both genders will be included * Written informed consent Exclusion criteria: * Pregnancy or unwilling to follow contraception or planning conception (Enrolled female patients will be strictly advised to avoid pregnancy during the study period and until 6 months after thalidomide withdrawal. * Hemoglobinopathies other than beta thalassemia * History of neurological problems * Inability to regularly follow up
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What it tests

  • Thalidomide
  • Hydroxy Urea
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Where

1 site
Riphah International University
Rawalpindi, Pakistan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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