Evaluation of the fffect of Defrasirox on MRIT2* and serum ferritin in major Thalassemia compared with Deferoxamine and Deferiprone in Gorgan Taleghani Hospital
The aim of this study is evaluation of the effect of Defrasirox on MRIT2* and serum ferritin in major Thalassemia compared with Deferoxamine and Deferiprone in Gorgan Taleghani Hospital. In this study, 58 patients with major thalassemia who receive regular blood and serum ferritin levels below 5000 and treated with deferiprone with deferoxamine were randomly divided into 2 groups. in intervention group previous drug discontinuate and treatment with Defrosyroxe began. In control group continue previous drugs. At the beginning and end of one year, heart and liver MRI T2* and every three months serum ferritin level in all patients review. after one year, the result of this therapy on serum ferritin and cardiac and liver MRI T2* in patients with major thalassemia compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071823245N1
Registration date:2015-11-12, 1394/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-12, 1394/08/21
Registrant information
Name
Ghazal Vaseghi
Name of organization / entity
Golestan univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 0926
Email address
ghazal_vaseghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Center of Golestan University Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the fffect of Defrasirox on MRIT2* and serum ferritin in major Thalassemia compared with Deferoxamine and Deferiprone in Gorgan Taleghani Hospital
Public title
Effect of Defrasirox on ferritin and iron overload in Thalassemia Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with major thalassemia with blood transfusions and treatment with Deferiprone with Deferoxamine; Ferritin levels below 5000ng/ml.
Exclusion criteria:The patient dissatisfaction; drug intolerance.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Not randomized
Randomization description
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
University ethics committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, beginning Shastkola road, 5 km Sari Gorgan road
City
Gorgan
Postal code
Approval date
2015-03-15, 1393/12/24
Ethics committee reference number
1107869312247
Health conditions studied
1
Description of health condition studied
major thalassemia
ICD-10 code
D56.9
ICD-10 code description
Thalassemia, unspecified
Primary outcomes
1
Description
serum ferritin
Timepoint
Baseline, 3 month6month,9month,12month
Method of measurement
sampling and serum ferritin level(ng/ml)
2
Description
changes of MRI T2* normally, involves mild, moderate, severe
Timepoint
baseline, after one year
Method of measurement
MRI and The speed Back in phase T2* With millisecondand and classificate into four groups: normal, mild, moderate, severe
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group previous treatment will be discontinued and patient will be treated with Defrosiroxe 20-40 mg/ kg/ day for one year
Category
Treatment - Drugs
2
Description
The control group will be treated with Deferoxamine 20-60 mg/ kg/ day in three doses with or without of Deferiprone 50-100 mg/ kg/ day in three doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgn Taleghani Hospital
Full name of responsible person
Ghazal Vseghi
Street address
Taleghani Hospital, Janbazan Blvd, Gorgan city, Golestan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Golestan University of Medical Sciences
Full name of responsible person
miss Nazari
Street address
Vice Chancellor for Research and Technology of Golestan Univercityof Medical Sciences, beginning of Shastkola road, 5 km Sari Gorgan road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Ghazal Vaseghi
Position
Resident of pediatrics
Other areas of specialty/work
Street address
Taleghani hospital, Janbazan blvd., Gorgan
City
Gorgan
Postal code
Phone
+98 17 3222 7720
Fax
Email
ghazal_vaseghi@yahoo
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan Univercity of Medical Sciences
Full name of responsible person
Narges Beigom Mirbebbahani
Position
Associate Professor
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan blvd., Gorgan
City
Gorgan
Postal code
Phone
+98 17 3222 7720
Fax
Email
n.mirbehbahani@gmail
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Taleghani Hospital
Full name of responsible person
Ghazal Vaseghi
Position
Resident of pediatrics
Other areas of specialty/work
Street address
Taleghani hospital, Janbazan blvd, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3222 7720
Fax
Email
ghazal_vaseghi@yahoo
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)