Comparison of the effect of deferasirox and deferiprone combination and defroxamine/deferiprone regimen on patients with beta-thalassemia
Design
This study will be conducted on β-thalassemia patients who are receiving deferoxamine plus deferiprone. 54 eligible patients will be randomly selected and randomly divided into two groups (27 patients in each group) . Patients in control group will receive deferoxamine + deferiprone and Patients in intervention group will receive deferasirox + deferiprone. The patients will be treated with these two regimens for at least 6 months. Monitoring of both groups will be done on a regular basis. Serum ferritin will be measured every three months. Cardiac MRI T2 * and the amount liver of iron will be measured before and after the study. All patients will be evaluated with the SF-36 questionnaire for measuring quality of life before and after the study.
Settings and conduct
54 patients with beta thalassemia who admitted to the thalassemia outpatient clinic at Tabriz Shahid Ghazi hospital will be selected randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patients with beta thalassemia who has beem referred to the outpatient clinic for routine blood transfusion and has receive deferoxamine+deferiprone
Exclusion criteria:
• Patients with hepatic impairment (ALT>5 times more than normal); Pregnancy; Patients with Renal impairment (GFR< 30 ml/min); Patients with chelating agent induced renal impairment
Intervention groups
Control group(27 patients): deferoxamine + deferiprone.
Intervention group (27 patients): deferasirox + deferiprone.
Serum ferritin will be measured every three months. Cardiac MRI T2 * and the amount liver of iron will be measured before and after the study. All patients will be evaluated with the SF-36 questionnaire for measuring quality of life before and after the study.
Main outcome variables
Ferritine level; MRI indinces; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160310026998N7
Registration date:2018-05-05, 1397/02/15
Registration timing:registered_while_recruiting
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Saba Ghaffary
Name of organization / entity
Faculty of Pharmacy, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33266042
Email address
ghaffarys@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of deferasirox and deferiprone combination and defroxamine/deferiprone regimen among patients with beta-thalassemia
Public title
Efficay comparison two oral chelators combination in patients with beta-thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
β thalassemia patients who have continuous blood transfusions receiving deferoxamine with deferiprone.
Exclusion criteria:
Patients who changes their chelator during the study.
Patients who changes thier blood transfusion pattern during the study
Patients with liver complications (rise of aminotransferase >5 times of baseline)
Pregnant women
Patients with renal insufficiency with a creatinine clearance (GFR) of less than 30 ml / min.
patients with renal adverese effect of chelating agent (rise serum creatinine>2 time of baseline orproteinuria)
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
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 Tabriz University of Medical Sciences
Street address
Shahid ghazi hospital, Tabriz University of Medical Sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
51665158
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.TBZMED.REC.1396.1239
Health conditions studied
1
Description of health condition studied
Two oral chelattor consumption in patients with beta thalassemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ferritine level
Timepoint
baseline and after 6 months
Method of measurement
blood sample
2
Description
Quality of life
Timepoint
baseline and after 6 months
Method of measurement
Questionare
3
Description
MRI indinces
Timepoint
baseline and after 6 months
Method of measurement
MRI
Secondary outcomes
empty
Intervention groups
1
Description
Patients in intervention group will receive Deferasirox + Deferiprone. Deferiprone will be consumed with a previous dosage and deferasirox will be administered in a standard dosage range (20-40 mg/kg). patients will receive this combination regimen for 6 month. Chelators produced by Avecina and Osve company will be used.
Category
Treatment - Drugs
2
Description
Patients in control group will receive Deferoxamine + Deferiprone. Both will be consumed with a previous dosage. patients will receive this combination regimen for 6 month. Chelators produced by avecina and roonak daroo company will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia and Hemophilia out patient clinic of Tabriz Shahid Ghazi hospital
Full name of responsible person
Saba Ghaffary
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah street
City
tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3336 5010
Email
ghaffarys@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saba Ghaffary
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3336 5010
Fax
Email
ghaffarys@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available