Status:
RECRUITING
Effects of Hydroxyurea and Metformin in Transfusion Dependent Beta-Thalassemia
Lead Sponsor:
Bahria University
Conditions:
Transfusion Dependent Beta-thalassemia
Eligibility:
All Genders
10-25 years
Phase:
PHASE4
Brief 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 si...
Detailed Description
The study will be conducted after obtaining approval from the Institutional Review Board (IRB) at Bahria University Health Sciences Campus Karachi (BUHSCK) and the Faculty Research Committee (FRC). Af...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Failure to meet inclusion criteria
- Refusal to participate
- Creatinine \>1.4mg/dL
- Liver function tests (ALT and conjugated bilirubin) \> 4 times upper limits of normal
- Massive splenomegaly \& Liver fibrosis
- Patient on growth hormone
- Sickle beta thalassemia
- Severe osteoporosis
- Hepatitis B \& C
- HIV
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06606886
Start Date
September 16 2024
End Date
April 30 2026
Last Update
December 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bahria University Health Sciences Campus
Karachi, Sindh, Pakistan