Efficacy and safety of triple iron chelator (deferoxamine, deferasirox, and deferiprone) versus dual iron chelator (deferoxamine and deferasirox) combination therapy for reducing iron overload in transfusion-dependent beta-thalassaemia with very high iron overload.
Phase 2
- Conditions
- Thalassaemia
- Registration Number
- SLCTR/2023/010
- Lead Sponsor
- Prof Anuja Premawardhena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1.Male or female patients.
2.Transfusion-dependent beta-thalassemia major requiring at least eight transfusions per year.
3.Aged over 12 years.
4.Serum ferritin >3500ng/mL in the last two measurements done over the preceding 3-month.
5.Currently on combination therapy with deferoxamine and deferasirox.
Exclusion Criteria
1.Pregnant and lactating females.
2.History of severe adverse effects to any of the three iron chelator chelators
3.Contraindications for any of the three iron chelators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in iron overload, as measured by a reduction in the serum ferritin concentration after completion of the treatment. [Baseline, after completion of 6-month treatment]<br>
- Secondary Outcome Measures
Name Time Method Reduction in liver iron content as measured by T2* MRI of the liver [Baseline, after completion of 6-month treatment]<br>Reduction in cardiac iron content as measured by T2* MRI of the heart [Baseline, after completion of 6-month treatment]<br> Side effects of trial medication [ After completion of 6-month treatment]<br>