The comparison of the efficacy of Iranian Deferasirox (Osveral®) and Exjade® on serum ferritin in patients with major beta-thalassemia
Design
Phase II randomized open-label clinical trial
Settings and conduct
This study was conducted on β-thalassemia major patients, who attended to thalassemia center of Bu-Ali Sina hospital in Sari, Iran.
Participants/Inclusion and exclusion criteria
The criteria for screening and entering the study were male or female patients with β-thalassemia major; age>2 year; ferritin level above 1000 mg/dL or the volume of blood transfusion above 100 mL/kg. All patients with pregnancy or breast-feeding state; progressive or persistent increase in the creatinine level; any cardiac, auditory or ophthalmic problems; hepatitis B or C, and HIV; persistent liver transaminases above 5-fold of the normal level; severe nausea and vomiting; hypersensitivity to deferasirox; severe skin rashes, progressive proteinuria and non-compliant or unreliable patients were excluded.
Intervention groups
The patients of Group 1 were received Osveral® and group 2 received Exjade®
Main outcome variables
The mean changes in serum ferritin concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090813002342N9
Registration date:2018-10-23, 1397/08/01
Registration timing:retrospective
Last update:2018-10-23, 1397/08/01
Update count:0
Registration date
2018-10-23, 1397/08/01
Registrant information
Name
Mohammad Reza Rafati
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
mrrafati@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
2015-08-03, 1394/05/12
Actual recruitment end date
2016-09-01, 1395/06/11
Trial completion date
2016-11-01, 1395/08/11
Scientific title
The comparison of the efficacy of Iranian Deferasirox (Osveral®) and Exjade® on serum ferritin in patients with major beta-thalassemia
Public title
The efficacy of Iranian Deferasirox (Osveral®) and Exjade® in the treatment of patients with major beta-thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female patients with β-thalassemia major
Age>2 year
Ferritin level above 1000 mg/dL or the volume of blood transfusion above 100 mL/kg
Exclusion criteria:
Patients with pregnancy or breast-feeding state
Progressive or persistent increase in the creatinine level
Any cardiac, auditory or ophthalmic problems
Hepatitis B (HBV) or C (HCV) and human immunodeficiency virus (HIV) infections
Persistent liver transaminases above 5-fold of the normal level
Severe nausea and vomiting
Hypersensitivity to deferasirox
Sever skin rashes
Progressive proteinuria
Non-compliant or unreliable patients
Age
From 2 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used to randomize patients to receive either Osveral® or Exjade®. Patients eligible for inclusion in the study were randomly assigned based on the random number table.
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 Mazandaran University of Medical Sciences
Street address
Payambar Azam Complex, 18 Km Farah Abad Blvd., Khazar Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
861-48175
Approval date
2015-08-31, 1394/06/09
Ethics committee reference number
IR.MAZUMS.REC 94-1069
Health conditions studied
1
Description of health condition studied
Beta thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
changes in serum ferritin concentration
Timepoint
bimonthly along 6 months
Method of measurement
Laboratory measurement of serum ferritin level
Secondary outcomes
1
Description
Mean changes of cardiac and liver MRI T2*
Timepoint
Baseline and a year after starting of the treatments
Method of measurement
Measurement of T2* by Magnetic Resonance Imaging (MRI)
2
Description
Drug safety and tolerability
Timepoint
Every two months to one year after treatment
Method of measurement
Question from patient and examination
Intervention groups
1
Description
Intervention group 1: Iranian Deferasirox (Osveral®), dose 30 mg/kg/day, single daily dose, half an hour before breakfast, for 6 months, made by Osvah Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Intervention group 2: Exjade®, dose 30 mg/kg/day, single daily dose, half an hour before breakfast, for 6 months, made by Novartis Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina hospital
Full name of responsible person
Dr. Mohammad Reza Rafati
Street address
Bu-Ali Sina Hospital, Pasdaran Blvd., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 7837
Email
mrrafati@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Mazandaran University of Medical Sciences, Deputy of Research and Technology, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rafati
Position
Associate Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3081
Email
mrrafati@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rafati
Position
Associate Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3081
Email
mrrafati@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rafati
Position
Associate Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3081
Email
mrrafati@mazums.ac.ir
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
No sufficient permission has been obtained to disseminate patient information.
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