Completed

NCT Number: NCT06468423

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

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.

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Key information

Conditions

Pateints of β-thalassemia Major With Iron Overload

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Multan, Punjab Province, 59210, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deferasirox (DFX)

Drug

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

Other names: Deferasirox

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.

Other names: Deferoxamine

Primary outcomes

Mean Serum Ferritin Levels

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 21, 2024
Registry last updated: Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.