1. Home
  2. Approved trials
  3. » فارسی

A clinical trial comparing the effectiveness of deferoxamine–deferasirox, deferasirox–deferiprone, and deferoxamine–deferiprone combinations in patients with beta-thalassemia major and severe iron overload

Protocol summary

Study aim
To compare the effectiveness of deferoxamine–deferasirox, deferasirox–deferiprone, and deferoxamine–deferiprone combinations in patients with beta-thalassemia major and severe iron overload
Design
A clinical trial with three intervention groups, parallel design, non-randomized, single-blinded, will be conducted on 105 patients.
Settings and conduct
Patients with beta-thalassemia and severe iron overload, selected at Dr. Sheikh Hospital in Mashhad, will be non-randomly assigned to three treatment groups. The study is single-blinded, meaning that the data collectors are unaware of which participants are in which group and of the type of treatment method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children with beta-thalassemia major and severe iron overload who have not achieved adequate iron control with monotherapy; age above 5 years; severe iron overload defined as serum ferritin greater than 2500 ng/dl or severe/very severe iron overload reported in cardiac and hepatic MRI. Exclusion criteria: Having chronic infectious diseases such as hepatitis; having proteinuria; having study drugs allergies.
Intervention groups
Group 1: Deferasirox (oral tablet, 14–28 mg/kg once daily for ≥6 months) plus Deferoxamine (subcutaneous infusion, 30–50 mg/kg over 8–12 hours, at least 5 times per week for ≥6 months). Group 2: Deferasirox (oral tablet, 14–28 mg/kg once daily for ≥6 months) plus Deferiprone (oral tablet, 75–80 mg/kg in three divided doses daily for ≥6 months). Group 3: Deferoxamine (subcutaneous infusion, 30–50 mg/kg over 8–12 hours, at least 5 times per week for ≥6 months) plus Deferiprone (oral tablet, 75–80 mg/kg in three divided doses daily for ≥6 months).
Main outcome variables
Serum ferritin levels, hepatic and cardiac iron concentrations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251214068323N1
Registration date: 2026-01-07, 1404/10/17
Registration timing: prospective

Last update: 2026-01-07, 1404/10/17
Update count: 0
Registration date
2026-01-07, 1404/10/17
Registrant information
Name
Hamid Farhangi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 3943
Email address
farhangih@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing the effectiveness of deferoxamine–deferasirox, deferasirox–deferiprone, and deferoxamine–deferiprone combinations in patients with beta-thalassemia major and severe iron overload
Public title
The effectiveness of drug combination in patients with beta-thalassemia major and severe iron overload
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with beta-thalassemia major and severe iron overload who have not achieved adequate iron control with monotherapy. Age above 5 years Severe iron overload defined as serum ferritin greater than 2500 ng/dl or severe/very severe iron overload reported in cardiac and hepatic MRI Absence of congenital heart disease Absence of chronic viral hepatitis infection Absence of heart failure
Exclusion criteria:
Having chronic infectious diseases such as hepatitis Serum creatinine level increased by more than 25% above baseline Having proteinuria ALT level elevated more than five times the normal value Having study drugs allergies
Age
From 5 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data collectors are blinded to group allocation and treatment method.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Faculty of Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2025-11-04, 1404/08/13
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1404.420

Health conditions studied

1

Description of health condition studied
Beta-thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
Serum ferritin levels
Timepoint
1, 2 and 3 months after intervention
Method of measurement
ELISA Ferritin Assay Kit

2

Description
Hepatic iron concentration
Timepoint
12 months after intervention
Method of measurement
Magnetic resonance imaging (MRI)

3

Description
Cardiac iron concentration
Timepoint
12 months after intervention
Method of measurement
Magnetic resonance imaging (MRI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured by Novartis, widely used to reduce iron overload resulting from frequent blood transfusions.In addition, they will be treated with Deferoxamine (subcutaneous infusion, 30–50 mg/kg administered over 8–12 hours, at least five times per week, for a minimum of six months). Deferoxamine is an injectable iron chelator, typically delivered via a portable infusion pump, and is also produced by Novartis. This drug is specifically indicated for lowering iron burden in patients with thalassemia major.
Category
Treatment - Drugs

2

Description
Intervention Group 2: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured by Novartis, commonly prescribed to reduce iron overload in transfusion-dependent thalassemia patients.In addition, they will be treated with Deferiprone (oral tablet, 75–80 mg/kg per day, administered in three divided doses, for a minimum of six months). Deferiprone is another iron chelator, typically produced by Apotex, and is widely used in combination therapy to enhance iron removal from both plasma and intracellular compartments.
Category
Treatment - Drugs

3

Description
Intervention Group 3: Patients in this group will receive Deferoxamine at a dose of 30 to 50 mg/kg body weight, administered as a subcutaneous infusion over 8 to 12 hours, at least 5 times per week, for a minimum duration of 6 months. Deferoxamine is an injectable iron chelator, typically delivered via a portable infusion pump, and manufactured by Novartis. This drug is specifically indicated for reducing iron stores in patients with thalassemia major.In addition, patients will receive Deferiprone as an oral tablet at a dose of 75 to 80 mg/kg body weight per day, divided into 3 daily doses, for at least 6 months. Deferiprone is an oral iron chelator, commonly produced by Apotex, and is particularly used to enhance iron excretion from plasma and intracellular compartments.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Hamid Farhangi
Street address
Dr. Sheikh Pediatric Subspecialty Hospital, Dr. Sheikh Street, Tohid Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Fax
+98 915 512 4538
Email
farhangih@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodii
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778 99191
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Farhangi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Sheikh Pediatric Subspecialty Hospital, Dr. Sheikh Street, Tohid Square
City
Mashad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Fax
Email
farhangih@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Farhangi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Sheikh Pediatric Subspecialty Hospital, Dr. Sheikh Street, Tohid Square
City
Mashad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Fax
Email
farhangih@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Farhangi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Sheikh Pediatric Subspecialty Hospital, Dr. Sheikh Street, Tohid Square
City
Mashad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3727 3943
Fax
Email
farhangih@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Hamid Farhangi provides the data analysis to the applicants via email: farhangih@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can send a message to the respondent’s email and will receive a reply within one week.
Comments
Loading...