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Clinical trial

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

ID
Name
RESnTEC
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-09-30
Trial end
2023-09-30
Status
Completed
Treatment
Deferasirox (DFX)
Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.
Arms:
Deferasirox (DFX) group
Other names:
Deferasirox
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 for a duration of 6 months.
Arms:
Desferioxamine (DFO) group
Other names:
Deferoxamine
Size
142
Primary endpoint
Mean Serum Ferritin Levels
6 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 142, 'type': 'ACTUAL'}}
Updated at
2024-06-21

1 organization

2 products

1 indication

Organization
Resntec Institute of Research
Product
Deferasirox
Indication
Patients of β-thalassemia Major With Iron Overload
Product
Deferoxamine