NCT06606886CompletedPhase 4
Effects of Hydroxyurea and Metformin in Transfusion Dependent Beta-Thalassemia
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 11 Sept 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 9 Feb 2026
- Lead sponsor
- Bahria University
- Diseases
- Thalassaemia
- NCT number
- NCT06606886
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 96
- From 16 Sept 2024 to the primary completion date, 9 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Failure to meet inclusion criteria
- Hepatitis B \& C
- HIV
Lab values
- Creatinine \>1.4mg/dL
- Liver function tests (ALT and conjugated bilirubin) \> 4 times upper limits of normal
Other
- Refusal to participate
- Massive splenomegaly \& Liver fibrosis
- Patient on growth hormone
- Sickle beta thalassemia
- Severe osteoporosis
Who the study is looking for
- 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.
Age in the registry: 10 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bahria University Health Sciences Campus Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.