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

NCT06468423 | Completed

• 1 other identifier: RESnTEC
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Pateints of β-thalassemia Major With Iron Overload

Outcome Measures

Primary Outcomes (1)

• Mean Serum Ferritin Levels

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

  6 months

Study Arms (2)

Deferasirox (DFX) group

EXPERIMENTAL

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.

Drug: Deferasirox (DFX)

Desferioxamine (DFO) group

EXPERIMENTAL

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

Drug: Deferoxamine (DFO)

Interventions

Deferasirox (DFX) DRUG

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

Also known as: Deferasirox

Deferasirox (DFX) group

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.

Also known as: Deferoxamine

Desferioxamine (DFO) group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
• Iron overload (serum ferritin level above 1000 µg/L)

You may not qualify if:

• 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

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

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

Multan, Punjab Province, 59210, Pakistan

Location

MeSH Terms

Interventions

Deferasirox; Deferoxamine

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydroxamic Acids; Hydroxylamines; Amines; Hydroxy Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)