The effect of exjade and its combination therapy with desferal is compared with the reduction of ferritin in patients with thalassemia major.
Design
This randomized clinical trial was conducted on thalassemic patients over 5 years old with thalassemia major, which is TDM. Based on the criteria for entry of children over 5 years of age with thalassemia major and Exclusion criteria for patients with hepatitis and HIV, and patients with renal and hepatic failure who do not have oral exjade. Patients are divided into two equal groups of 25 people. An exjade group received 30 mg / kg / day of the single dose of 30 mg / kg in the morning and the second group, in addition to the exjade, desferal injection of 50 mg / kg subcutaneously with desferal pump and monthly serum ferritin levels were checked for 6 months and the study was completed together It is compared
Settings and conduct
Children with thalassemia major referring to Amirkabir hospital in Arak are randomly divided into two groups of 25 people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children over 5 years old with thalassemia major
Exclusion criteria: Hepatitis and HIV, kidney and liver failure
Intervention groups
Group 1: treated with the exjade group daily 30 mg / kg single dose of morning fasting
Group 2: In addition to exjade, desferal ampoule 50 mg / kg subcutaneously with desferal pump
Main outcome variables
Serum ferritin levels are checked for 6 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020715N4
Registration date:2017-12-17, 1396/09/26
Registration timing:retrospective
Last update:2017-12-17, 1396/09/26
Update count:0
Registration date
2017-12-17, 1396/09/26
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Arak university of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-05-22, 1396/03/01
Trial completion date
empty
Scientific title
Evaluation of exjade effect & combination therapy with deferoxamine in patients with thalassemia major
Public title
Evaluation of exjade effect & combination therapy with deferoxamine in patients with thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Children over 5 years old with thalassemia major Exclusion criteria: People under 5 years of age with hepatitis and HIV; patients who do not have a study entry; patients with kidney and liver failure; and no exjade oral tolerance.
Exclusion criteria:
Inclusion criteria: Children over 5 years old with thalassemia major Exclusion criteria: People under 5 years of age with hepatitis and HIV; patients who do not have a study entry; patients with kidney and liver failure; and no exjade oral tolerance.
Age
From 5 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Patients are ranked among the control and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants and researchers are unaware of the allocation of study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Sardasht St, Faculty of Medicine
City
Arak
Province
Markazi
Postal code
3819838453
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.ARAKMU.REC.1395.220
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56
ICD-10 code description
Thalassemia
Primary outcomes
1
Description
ferritin
Timepoint
6 months after starting treatment
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: treated with exjade daily 30 mg / kg single dose of fasting in the morning
Category
Treatment - Drugs
2
Description
Group 2: In addition to exjade, deferral ampoule 50 mg / kg subcutaneously with desferal pump
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amirkabir Hospital
Full name of responsible person
Pooria Shokri
Street address
Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3817874797
Phone
+98 86 3465 5314
Email
rahenorayaneh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Dr. Mohammad Rafiei
Street address
Arak, School Medicine
City
Arak
Province
Markazi
Postal code
3817874797
Phone
+98 86 3465 5314
Email
rahenorayaneh@yahoo.com
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
Pooria Shokri
Position
General practitioner
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Arak , Faculty of Medicine
City
Arak
Province
Markazi
Postal code
3817874797
Phone
+98 86 3465 5314
Fax
Email
rahenorayaneh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Dr. Aziz Eghbali
Position
Blood specialist and oncology children
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Arak, AmirKabir Hospital
City
Arak
Province
Markazi
Postal code
3817874797
Phone
+98 86 3465 5314
Fax
Email
rahenorayaneh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Pooria Shokri
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Arak, Faculty of Medicine
City
Arak
Province
Markazi
Postal code
3817874797
Phone
+98 86 3465 5314
Fax
Email
rahenorayaneh@yahoo.com
Web page address
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
Participants information will remain confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available