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Thalidomide and hydroxyurea together for people with beta thalassemia

Tests thalidomide with hydroxyurea for safety and effect in people with beta thalassemia.

Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia

Key facts

Where
Rawalpindi, PakistanSee the site

Where in Pakistan

  • Riphah International UniversityRawalpindi, PakistanTaking people

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  2. Are travel costs paid?
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  4. What happens if I want to stop?
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Trial details

Who runs it
Riphah International University
Trial code
NCT07673302
Record updated
6 August 2026
Original description
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:Read full original descriptionShow less

Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia: a Prospective 12 Months Study

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

Inclusion: 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 β-thalassemia syndrome; All ages and both genders will be included; Written informed consent.

Exclusion: History of neurological problems; 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; Inability to regularly follow up.

ClinicalTrials.gov NCT07673302