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Deciphering Effects of Thalidomide on Red Blood Cells in Transfusion Dependents Beta Thalassemia Patients

NCT06146478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-24

No results posted yet for this study

Summary

The goal of this Non-Randomized Clinical Trial is to determine the effects of thalidomide on red blood cells in transfusion dependent beta thalassemia patients. The main aims of this study are:

* To determine the therapeutic effect of Thalidomide on hemoglobin.
* To analyze association of different β- globin mutations with response to thalidomide in β-thalassemia patients.
* To analyze association of Single Nucleotide Polymorphisms (SNPS) of HBG2, BCL11A and HBS1L-MYB with response to thalidomide in β-thalassemia patients.
* To correlate GATA1 and KLF1 gene expression with response to thalidomide in β-thalassemia patients.

Patients will be grouped into thalidomide and non-thalidomide groups on the basis of their willingness to receive thalidomide therapy. Thalidomide will be given at an average dose of 1.5mg/kg/day (range 1-2mg/kg/day). Patients will be followed up for 12 months and data will be collected at different visits. After 12 months of thalidomide therapy patients will be divided into responders and non-responders for comparative analyses on the basis of increase in hemoglobin level.

Conditions

Interventions

DRUG

Thalidomide

Thalidomide given at an average dose of 1.5mg/kg/day

Sponsors & Collaborators

  • Khyber Medical University Peshawar

    collaborator OTHER

  • Blood Care Clinic

    lead OTHER

Principal Investigators

  • Sami Siraj, PhD · Institute Of Pharmaceutical Sciences, Khyber Medical University Peshawar

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2023-07-20
Completion
2023-10-31

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146478 on ClinicalTrials.gov