Effects of Hydroxyurea and Metformin in Transfusion Dependent Beta-Thalassemia

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 25
Healthy Volunteers: f
View:

• Diagnosed cases of beta-thalassemia major

• Transfusion dependent patients and on iron chelating agents

• Males and females 10 to 25 years of age

• Creatinine ≤1.4 mg/dL

• Written informed consent from the patients and up to 18 years consent from the Parents/Guardians.

Locations
Other Locations
Pakistan
Bahria University Health Sciences Campus
RECRUITING
Karachi
Contact Information
Primary
Ayesha Khan
dr.ayeshakhan85@gmail.com
+923363258465
Backup
Nasim Karim
nasimkarim.bumdc@bahria.edu.pk
+923323151774
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 96
Treatments
Active_comparator: (Group A) Tablet Metformin
Tablet Metformin 500 mg/dose orally twice a day with meal for 1 year
Active_comparator: (Group B) Tablet Hydroxyurea
Tablet Hydroxyurea 10-20mg/kg once daily orally with breakfast for 1 year
Sponsors
Leads: Bahria University

This content was sourced from clinicaltrials.gov