Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload

RESnTEC, Institute of Research

Status: Completed

Conditions: Pateints of β-thalassemia Major With Iron Overload

Treatments: Drug: Deferasirox (DFX); Drug: Deferoxamine (DFO)

Study type: Interventional

Funder types: Other

Identifiers

NCT06468423

RESnTEC

Details and patient eligibility

About

This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.

Enrollment: 142 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
• Iron overload (serum ferritin level above 1000 µg/L)

Exclusion criteria

• Patients with other transfusion-dependent anemias
• Thalassemia major with cardiomyopathy or arrhythmia.
• Chronic renal failure
• Chronic liver disease (ALT >200 IU)
• Hhypersensitivity to deferasirox or desferrioxamine
• Patients already on combined chelation therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Deferasirox (DFX) group

Experimental group

Description:

DFX group (n=71) included children who used oral (tablet) DFX at a dose of 30 mg/kg once daily for a duration of 6 months.

Treatment:

Drug: Deferasirox (DFX)

Desferioxamine (DFO) group

Experimental group

Description:

DFO group (n=71) included children who were given DFO at a dose of 50 mg/kg through the subcutaneous route by infusion pump five days a week

Treatment:

Drug: Deferoxamine (DFO)