A comparison study of the effects of Jadenu®️(Deferasirox) film-coated tablets and Exjade®️(Deferasirox) tablets for oral suspension on reducing liver and heart iron overload in patients with Beta-Thalassemia Major and Intermedia
Comparison of the effect of Exjade® and Jadenu on the mean reduction of iron deposition in the heart and liver in patients with beta thalassemia major and intermedia
Design
he present study is a randomized controlled clinical trial in which patients will be randomly divided into two equal groups (n = 33). One group will be given Exjade® and the other group will be given Jadenu.
Settings and conduct
The present study is a randomized controlled clinical trial in which patients will be randomly divided into two equal groups (n = 33).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 2 years old
patients with Beta-Thalassemia Major and Intermedia
Serum ferritin above 1000 μg / mL
Having informed consent to enter the study
No entry conditions
Having contraindication to Jadenu®️and Exjade®️
Patients with GFR ˂40 mL / min / 1.73 m^2
Patients with stunted growth
Patients with High-risk myelodysplastic syndromes (MDS)
malignant cancer
patients with platelet lower than 50x 10^9/L
Patients with prior knowledge of allergy to drugs of the defrazirox group
Patients with liver failure
Patients with gastrointestinal bleeding
Patients with renal failure
Using other iron chelators at the same time
age over 50 years old
Intervention groups
The control group receives Exjade and the intervention group receives Jadenu.
Main outcome variables
Cardiac iron load- Liver iron Load- Aspartate aminotransferase- Alanine transaminase-Existence of gastrointestinal side effects - level of satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210830052346N1
Registration date:2021-11-09, 1400/08/18
Registration timing:registered_while_recruiting
Last update:2021-11-09, 1400/08/18
Update count:0
Registration date
2021-11-09, 1400/08/18
Registrant information
Name
Mahya Mobinikhaledi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 5382
Email address
mahya.mobini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-09, 1400/08/18
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of the effects of Jadenu®️(Deferasirox) film-coated tablets and Exjade®️(Deferasirox) tablets for oral suspension on reducing liver and heart iron overload in patients with Beta-Thalassemia Major and Intermedia
Public title
Effect of Jadenu®️and Exjade®️on reducing liver and heart iron overload in Beta-Thalassemia Major and Intermedia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 2 years old
patients with Beta-Thalassemia Major and Intermedia
Serum ferritin above 1000 μg / mL
Having informed consent to enter the study
Exclusion criteria:
Having contraindication to Jadenu®️and Exjade®️
Patients with GFR ˂40 mL / min / 1.73 m^2
Patients with stunted growth
Patients with High-risk myelodysplastic syndromes (MDS)
malignant cancer
patients with platelet lower than 50x 10^9/L
Patients with prior knowledge of allergy to drugs of the defrazirox group
Patients with liver failure
Patients with gastrointestinal bleeding
Patients with renal failure
Using other iron chelators at the same time
age over 50 years old
Age
From 2 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
No. 2, Sepahdar4, Sevom shaban st
City
َArak
Province
Markazi
Postal code
3815935139
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.ARAKMU.REC.1399.250
Health conditions studied
1
Description of health condition studied
Beta Thalasemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
cardiac iron load
Timepoint
At the beginning of the study and 6 months after taking Exjade or Jadenu
Method of measurement
T2*MRI
2
Description
liver iron load
Timepoint
At the beginning of the study and 6 months after taking Exjade or Jadenu
Method of measurement
T2*MRI
3
Description
Aspartate aminotransferase(AST)
Timepoint
At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu
Method of measurement
The patient's serum is separated by centrifugation and given to an autoanalyzer
4
Description
Alanine transaminase(ALT)
Timepoint
At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu
Method of measurement
The patient's serum is separated by centrifugation and given to an autoanalyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that receives Jadenu. Jadenu is part of the drug class deferasirox . 33 people are being treated with Deferasirox (Jadenu®) for 6 months. This drug will be given as a swallowable tablet at a dose of 20 mg / kg per day (once a day, daily for 6 months, by Novartis Pharma AG, Basel, Switzerland) to patients in this group. we start the treatment with the dose of 20 mg / kg and increase the dose to 40 mg / kg if needed.
Category
Treatment - Drugs
2
Description
Control group: The group that receives Exjade. Exjade is part of the drug class deferasirox. 33 people are being treated with Exjade for 6 months. It is given as a granule tablet at a dose of 20 mg / kg per day (once a day, daily for six months, by Novartis Pharma AG, Basel, Switzerland). Start treatment with a dose of 20 mg / kg and increase the dose to 40 mg / kg if needed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Vahid Falahati
Street address
Shahid Shirodi, Rahan st
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 5075
Email
mahya.mobini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Almasi
Street address
No2, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 6055
Email
modavem@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Vahid falahati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology & Oncologisy
Street address
No. 2, Sepahdar 4, Sevom Shaban st
City
Arak
Province
Markazi
Postal code
3815935139
Phone
+98 86 3277 5382
Email
mahya.mobini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Falahati
Position
َAssisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Hematology and Oncology
Street address
No. 2, Sepahdar 4, Sevom Shaban st
City
Arak
Province
Markazi
Postal code
3815935139
Phone
+98 86 3277 5382
Email
mahya.mobini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Falahati
Position
َAssisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
No. 2, Sepahdar 4, Sevom Shaban st
City
Arak
Province
Markazi
Postal code
3815935139
Phone
+98 86 3277 5382
Email
mahya.mobini@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of the information, patient information is kept confidential by the project manager