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Completed
NCT06299670
Efficacy of Combination of Hdroxyurea and Thalidomide Over Hydroxyurea or Thalidomide in the Treatment of Transfusion Dependent Thalassemia in Children
Conditions: Transfusion-dependent Thalassemia
Sex: All
Ages: 3 Years – 18 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 90
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Location: Bangabandhu Sheikh Mujib Medical University Dhaka
Summary
The goal of this clinical trial is to find out the efficacy of combined Hydroxyurea and thalidomide transfusion dependent thalassemia patients. The main objectives are to compare the level of Hb, Transfusion interval, serum ferritin level before \& after treatment between single and combination of thalidomide and HU.
Researcher will compare the effectiveness of combined hydroxyurea and thalidomide and hydroxyurea and thalidomide alone. Participants will be divided in three groups:
Group I: will take combination of HU and Thalidomide. Group II: Will take HU alone and Group III: Will take Thalidomide alone and outcome will be recorded.
Eligibility Criteria
Inclusion Criteria:
* Patients diagnosed as transfusion dependent thalassemia
* Age ranged from 3-18 years
* Blood transfusion more than 1 year.
* no bleeding disorder
Exclusion Criteria:
* Active systemic co-morbidity,
* Past personal or family history of thrombophilia,
* Recent fracture or recent major surgery
* Use of drugs that might affect Hb levels 15 days before enrollment
Source: ClinicalTrials.gov (NCT06299670). StuddyBuddy aggregates publicly available trial information.