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

June 15, 2024 updated by: RESnTEC, Institute of Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 59210
        • Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Deferasirox (DFX)
Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.
Other Names:
  • Deferasirox
Experimental: 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
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.
Other Names:
  • Deferoxamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Serum Ferritin Levels
Time Frame: 6 months
Change in mean serum ferritin level from baseline for each group.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RESnTEC, Institute of Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESnTEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared with other researchers on a reasonable resquest to parimary researcher.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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