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

Not Applicable

Completed

• Conditions: Pateints of β-thalassemia Major With Iron Overload
• Interventions: Drug: Deferasirox (DFX); Drug: Deferoxamine (DFO)

• Registration Number: NCT06468423
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-15
• Last Update Submitted: 2024-06-15
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deferasirox (DFX) group	Deferasirox (DFX)	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.
Desferioxamine (DFO) group	Deferoxamine (DFO)	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

Primary Outcome Measures

Name	Time	Method
Mean Serum Ferritin Levels	6 months	Change in mean serum ferritin level from baseline for each group.

Trial Locations

Locations (1)

Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health; 🇵🇰 Multan, Punjab, Pakistan