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

RESnTEC, Institute of Research142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Pateints of β-thalassemia Major With Iron Overload

Interventions

Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.

Deferoxamine (DFO)DRUG

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 for a duration of 6 months.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health

Multan, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Mean Serum Ferritin Levels

Change in mean serum ferritin level from baseline for each group.

Time frame: 6 months

Data from ClinicalTrials.gov

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