Compare the efficacy of combination Deferasirox and Deferiprone with Deferoxamine and Deferiprone in reducing heart and liver iron load in patients with transfusion-Dependent β-Thalassemia.
The efficacy of combination of Deferasirox and Deferiprone in reducing iron load in patients with transfusion-Dependent β-Thalassemia
Design
Randomized,controlled clinical trial with a parallel group
Settings and conduct
This randomized clinical trial were don in 107 patients with transfusion-Dependent β-Thalassemia in thalassemia center of Isfahan, Omid hospital. all patient divided in two group ,group A (Defrasirox and Deferiprone ) and group B (Defroxamin and Deferiprone ), and investigated for six month.Heart and Liver MRI T2* were done before treatment and at the end of study. ّferritin level befor treatment and every three month measured. Change in ferritin level and Heart and liver iron concentration before and after treatment compare between two group
Participants/Inclusion and exclusion criteria
Age more than 10, Ferritin more than 1000, Heart and Liver iron load mild moderate and severe, Not receiving combination therapy and Liver and Renal normal function
Intervention groups
Group A: Deferasirox and Deferiprone group that Treat with Deferasirox and Deferiprone for six month
Group B:Defroxamin and Deferiprone group that Treat with Defroxamin and Deferiprone for six month
Main outcome variables
Heart and liver MRI T2*,Ferritin level, Liver function test, Renal function test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190106042262N1
Registration date:2019-03-02, 1397/12/11
Registration timing:retrospective
Last update:2019-03-02, 1397/12/11
Update count:0
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Ali Reza Fazeli Varzaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3527 6082
Email address
rezaali.fazeli6768@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2018-02-19, 1396/11/30
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-12-21, 1397/09/30
Scientific title
Compare the efficacy of combination Deferasirox and Deferiprone with Deferoxamine and Deferiprone in reducing heart and liver iron load in patients with transfusion-Dependent β-Thalassemia.
Public title
Compare the efficacy of combination therapy of Deferasirox and Deferiprone in reducing iron load in patients with transfusion-Dependent β-Thalassemia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients with transfusion-Dependent β-Thalassemia with ferritin more than 1000
All Patients with transfusion-Dependent β-Thalassemia who were not treated with combination iron chelators
All Patients with transfusion-Dependent β-Thalassemia with heart and liver iron load
All Patients with transfusion-Dependent β-Thalassemia with normal liver and renal function
All Patients with transfusion-Dependent β-Thalassemia with age more than 10 years
Exclusion criteria:
Gastrointestinal problem before research
Age
From 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
107
Randomization (investigator's opinion)
Randomized
Randomization description
All samples encoded by a third person that does not participate in the research, and then by using a random digits table, patients were divided into two groups
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 Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8375174647
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
397106
Health conditions studied
1
Description of health condition studied
transfusion-Dependent β-Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Heart and liver iron concentration
Timepoint
At the start of research and six month later
Method of measurement
Magnetic resonance imaging T2*
Secondary outcomes
1
Description
Ferritin
Timepoint
At the start of research and third and sixth of study
Method of measurement
Serum ferritin level
Intervention groups
1
Description
Intervention group: for six month treated with Defrasirox (in this study we use Osveral 125mg, 250 and 500mg construction of Osvah Company of Iran) with 20-40 mg/kg daily and Deferiprone (construction of avicenna Company of Iran) with 15 mg/kg/dose in three dose
Category
Treatment - Drugs
2
Description
Control group: for six month treated with Defroxamin(Vial 500mg) with 20-50 mg/kg daily that infusion with a pomp and Deferiprone (construction of avicenna Company of Iran) with 15 mg/kg/dose in three dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalasemia center of Omid Hospital of Isfahan
Full name of responsible person
Alireza Fazeli varzaneh
Street address
Motahariَ
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 0210
Email
rezaali.fazeli6768@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Fazeli Varzaneh
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8375174647
Phone
+98 31 3527 6082
Email
rezaali.fazeli6768@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
alireza Fazeli Varzaneh
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8375174647
Phone
+98 31 3527 6082
Email
Rezaali.fazeli6768@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza fazeli varzaneh
Position
pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8375174647
Phone
+98 31 3527 6082
Email
rezaali.fazeli6768@gmail.com
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
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After the completion of the study, the protocol of study and the statistical analysis map, as well as all the data collected, including the individual data of the participants after unidentifiable people and main outcome will be presented in tables and diagrams in Result section of article.1
When the data will become available and for how long
Immediately after the publication of result
To whom data/document is available
Everyone is able to access
Under which criteria data/document could be used
For more study on patients with β-Thalassemia
From where data/document is obtainable
Refer to email: Rezaali.fazeli6768@gmail.com
What processes are involved for a request to access data/document
After receiving a request email, documentation will be sent within one week