Objectives: The goal of this study was to compare the efficacy of Osveral and Exjade in reducing iron overload of liver and heart and serum ferritin.
Design: This non-randomized RCT study was done in Mofid hospital. All patients with beta thalassemia in Mofid pediatric hospital in 1394 that did not have compliance of iron injection were enrolled the study.The patients were allocated to exjade and osveral groups according to economic level.Because the low economic level participants could not afford to buy exjade. This study was single center and 2th phase of clinical trial.
Setting and conduct: Inclusion criteria included equal or more than 2 years old, normal creatinine(cr) level, no proteinuria, negative for hepatitis B and C or HIV, hepatic transaminase less than 5 time above normal values, the ferritin level more than 1000 and transfusion more than 10 times.Exclusion criteria included severe heart failure, liver transaminase more than five folds, repeated cytopenia, nausea and vomiting, skin rashes and elevated serum Cr.
Intervention: The data belongs to two groups of people who received Deferasirox or Osveral as an iron chelator were gathered and analyzed. The duration of patient follow up was 12 months.
Main outcome measures: The ferritin level of serum was checked at the biginning of the study and every three months. The heart and liver MRI T2* findings were assessed before and after our intervention to confirm as the most sensitive ways of liver and heart iron load.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102524679N2
Registration date:2016-06-16, 1395/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Samin Alavi
Name of organization / entity
Mofid Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
s.alavi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on efficacy of Deferasirox (Exjade) versus Osveral in treatment of iron overload in patients with beta thalassemia major
Public title
Effect of Osveral on iron overload in beta thalassemia major patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: equal or more than 2 years old; normal creatinine level; no proteinuria; negative for hepatitis B and C or HIV; hepatic transaminase less than 5 time above normal values; nornal CBC; No cardiac disorder; the ferritin level more than 1000; transfusion more than 10 times.
Exclusion criteria: severe heart failure; patients who can not tolerate MRI; keeping liver transaminase more than five folds; repeated cytopenia; nausea and vomiting; skin rashes; and elevated serum creatinine.
Age
To 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
69
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, velenjak
City
Tehran
Postal code
Approval date
2013-02-28, 1391/12/10
Ethics committee reference number
18227
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
serum ferritin
Timepoint
before the intervention and every 3 monthes
Method of measurement
ELISA method, ng/ml
2
Description
The liver iron overloads
Timepoint
at the biginning of the intervention and after 12 monthes
Method of measurement
MRI T2
3
Description
The heart iron overloads
Timepoint
at the biginning of the intervention and after 12 monthes
Method of measurement
MRI T2
Secondary outcomes
1
Description
AST
Timepoint
at the biginning of the study and every 3 monthes
Method of measurement
Specterophotometery method, mIU/l
2
Description
ALT
Timepoint
at the biginning of the study and every 3 monthes
Method of measurement
Specterophotometery method, mIU/l
3
Description
serum Creatinin
Timepoint
at the biginning of the study and every 3 monthes
Method of measurement
Jaffeh method, mg/dl
4
Description
urine Creatinin
Timepoint
at the biginning of the study and every 3 monthes
Method of measurement
mg/dl
5
Description
urine Pr
Timepoint
at the biginning of the study and every 3 monthes
Method of measurement
mg/dl
Intervention groups
1
Description
Intervention group 1: Osveral (Iron chelating agent, Osveh Company, Iran) was given as follows. The starting dose was 20 mg/kg/d for Osveral and the ferritin level measured each three months up to twelve months. The dose of drugs tailored to ferritin level for each patients at the rate of 5-10 mg/kg/d
Category
Treatment - Drugs
2
Description
Intervention group 2: ِDeferasirox (Exjade, Iron chelator agent, Novartis company, Switzerland) was given to this group. The starting dose was 20 mg/kg/d for Deferasirox and the ferritin level measured each three months up to 12 months. The dose of drugs tailored to ferritin level for each patients at the rate of 5-10 mg/kg/d
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital, Thalassemia Center
Full name of responsible person
Dr. Neda Ashayeri
Street address
Below the Mirdamad street, Shariati street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Neda Ashayeri
Street address
Mofid hospital. Shariati St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Mofid Hospital
Full name of responsible person
Neda Ashayeri
Position
Pediatricion
Other areas of specialty/work
Street address
Unit 11, NO. 15, 21th St., Saadat Abd St., Tehran
City
Tehran
Postal code
Phone
+886 86772
Fax
Email
neda_ashayeri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid beheshti university of medical sciences
Full name of responsible person
Dr.Samin Alavi
Position
pediatric hematology and oncology
Other areas of specialty/work
Street address
Mofid Hospital, Shariaati St., Tehran
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
Email
s.alavi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mofid Hospital
Full name of responsible person
Dr. Neda Ashayeri
Position
Pediatricion
Other areas of specialty/work
Street address
Unit 11, NO.15, 21th St., Saadatabad St., Tehran
City
Tehran
Postal code
Phone
+98 21 8868 6772
Fax
Email
neda_ashayer@ yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)