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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.

Efficacy and safety of deferoxamine, deferasirox, and deferiprone triple iron chelator combination therapy for transfusion-dependent beta-thalassaemia with very high iron overload

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2023/010
Enrollment
Unknown
Registered
2023-04-19
Start date
2023-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassaemia

Interventions

Patients with transfusion-dependent beta-thalassemia major with very high serum ferritin (>3500ng/mL) attending the Adult and Adolescent Thalassaemia Center of the Colombo North Teaching Hospital, Rag

Sponsors

Prof Anuja Premawardhena
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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]

Secondary

MeasureTime frame
Reduction in liver iron content as measured by T2* MRI of the liver [Baseline, after completion of 6-month treatment] Reduction in cardiac iron content as measured by T2* MRI of the heart [Baseline, after completion of 6-month treatment] Side effects of trial medication [ After completion of 6-month treatment]

Countries

Sri Lanka

Contacts

Public ContactProf Anuja Premawardhena

Professor in Medicine

premawa@hotmail.com+94112961000

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026