Comparison of Deferasirox and Desferoxamine in Patients o... | NCT06468423

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

NCT06468423

Sponsor

RESnTEC, Institute of Research

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

142Actual

Phase

Not Applicable

Conditions

Pateints of β-thalassemia Major With Iron Overload

Interventions

Deferasirox (DFX)
Deferoxamine (DFO)

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Sep 30, 2023Actual

Completion Date

Sep 30, 2023Actual

First Submitted Date

Jun 12, 2024

First Submission Date that Met QC Criteria

Jun 15, 2024

First Posted Date

Jun 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2024

Last Update Posted Date

Jun 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Deferasirox (DFX)	Drug	Oral DFX at a dose of 30mg/kg daily advised for a duration of 6 months.	Deferasirox (DFX) group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health		Multan	Punjab Province	59210	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077588	Deferasirox
D003676	Deferoxamine

Ancestor Terms

ID	Term
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

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