Pateints of β-thalassemia Major With Iron Overload
Conditions
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.
Interventions
DRUGDeferasirox (DFX)
Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.
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.
Sponsors
RESnTEC, Institute of Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Serum Ferritin Levels | 6 months | Change in mean serum ferritin level from baseline for each group. |
Countries
Pakistan
Outcome results
None listed