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

NCT ID: NCT06468423

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Pateints of β-thalassemia Major With Iron Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deferasirox (DFX) group

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.

Group Type EXPERIMENTAL

Deferasirox (DFX)

Intervention Type DRUG

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

Desferioxamine (DFO) group

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

Group Type EXPERIMENTAL

Deferoxamine (DFO)

Intervention Type 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.

Interventions

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Deferasirox (DFX)

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Deferasirox Deferoxamine

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RESnTEC, Institute of Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Multan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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RESnTEC

Identifier Type: -

Identifier Source: org_study_id