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Effects of Hydroxyurea and Metformin in Transfusion Dependent Beta-Thalassemia

NCT06606886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Transfusion Dependent Beta-thalassemia

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

Sponsors & Collaborators

  • Bahria University

    lead OTHER

Principal Investigators

  • Ayesha Khan, MBBS MPhil · Bahria University Islamabad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-16
Primary Completion
2026-02-09
Completion
2026-02-09

Countries

  • Pakistan

Study Locations

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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 NCT06606886 on ClinicalTrials.gov