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RECRUITING
NCT06606886
PHASE4

Effects of Hydroxyurea and Metformin in Transfusion Dependent Beta-Thalassemia

Sponsor: Bahria University

View on ClinicalTrials.gov

Summary

This clinical trial aims to evaluate and compare the effects and safety of hydroxyurea and metformin in transfusion-dependent beta-thalassemia major and correlate responders/non-responders with the single nucleotide polymorphism mutations (SNPs) by DNA analysis. The main question to answer is: * Is there a significant difference in the effects and safety of hydroxyurea and metformin in transfusion-dependent beta-thalassemia major? Participants will be divided into two treatment groups. Participants of group A will receive Tab. Metformin 500mg/dose twice daily orally for one year. Participants of group B will receive Tab. Hydroxyurea 10-20mg/kg once daily orally for one year. At the end of the study, Investigators will compare the effects and safety of hydroxyurea and metformin in transfusion-dependent beta-thalassemia major and correlate responders/non-responders with the single nucleotide polymorphism mutations (SNPs) by DNA analysis.

Key Details

Gender

All

Age Range

10 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-09-16

Completion Date

2026-04-30

Last Updated

2024-12-17

Healthy Volunteers

No

Interventions

DRUG

Tablet Metformin (Group A)

Tablet Metformin 500 mg/dose orally twice a day with meal for 1 year

DRUG

Tablet Hydroxyurea (Group B)

Tablet Hydroxyurea 10-20mg/kg once daily orally with breakfast for 1 year

Locations (1)

Bahria University Health Sciences Campus

Karachi, Sindh, Pakistan