Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability. Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials \& The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials. This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• Patients diagnosed as transfusion dependent thalassemia

• Age ranged from 3-18 years

• Blood transfusion more than 1 year.

• no bleeding disorder

Locations
Other Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University
RECRUITING
Dhaka
Contact Information
Primary
Md. Anwarul Karim, MBBS,FCPS, MD
drkarim1990@gmail.com
+880255165814
Backup
Mohammad Hafizurr Rahman, MBBS,MD
registrar@bsmmu.edu.bd
+8801521438565
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Thalidomide
Patient getting Thalidomide
Experimental: Hydroxyurea
Hydroxyurea
Experimental: Combination
combination of Thalidomide \& Hydroxyurea
Sponsors
Leads: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

This content was sourced from clinicaltrials.gov

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