Clinical Trial

Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia

Study acronym: BTM
Recruiting Phase 2
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Summary
The project "Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia" investigates the safety and efficacy of low-dose thalidomide in managing beta thalassemia, a genetic disorder causing anemia. Conducted over two years at NIBD hospital, the study involves 54 transfusion-dependent patients aged 8-35. The primary objective is to correlate thalidomide doses with disease severity, adverse effects, and treatment response, aiming to optimize treatment strategies and reduce side effects. Data will be collected through clinical interviews and medical record reviews and analyzed using SPSS. Key variables include hemoglobin levels, leukocyte and reticulocyte counts, platelets, liver and spleen size, genetic modifiers, and transfusion frequency. Inclusion criteria are specific to beta thalassemia patients, while exclusion criteria rule out those with liver dysfunction, married patients, lactating mothers, and those with a history of thrombosis or fits.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-28; most recent amendment 2025-05-26.
Trial Details
NCT Number NCT06490627
Lead Sponsor National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
Conditions Fetal Hemoglobin, Thalassemia Major, Genetic Disease
Enrollment 54 participants
Start Date 2024-04-22
Primary Completion 2025-04-22 (estimated)
Study Completion 2026-04-22 (estimated)
Updated on ClinicalTrials.gov 2025-05-30