The present study aims to compare the effect of combinatory and single therapies of exjade and desferal on ferritin level among patients with major thalassemia. It is a single blind clinic study. 90 patients with major thalassemia attending Mohammad Kermanshahi hospital, under treatment with Deferoxamine hypodermic injection and ferritin level 1000 to 3000 were chosen and randomly divided into three groups each including 30 individuals. The first group received the normal treatment including 40 mg/kg deferoxamine hypodermic daily, 6 days a week. The second group received exjade pills 20 mg/kg daily. The third group was treated with daily injection of 40 mg/kg of deferoxamine hypodermic 3 days a week; exjade pill 10mg/kg was taken simultaneously in the third group. Starfa was used to measure ferritin serum at the beginning of the study and every 3 month during 6 months. Inclusion: being younger than 18; having thalasemia major based on observing clinical symptoms and hemoglobin electrophoresis history; being treated by deferoxamine hypodermic injection and ferritin level 1000 to 3000. Exclusion: inability to digest exjade; hepatitis virologic; LFT; active hepatitis; noncompliance with previous treatment regimens; ALT and AST normal up to 3 times
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042114333N32
Registration date:2015-06-04, 1394/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-04, 1394/03/14
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-05-31, 1394/03/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparating the effect of combination and single therapy of exjade and desferal on ferritin level in patients with major thalassemia
Public title
The effect of therapy of exjade and desferal on ferritin level in patients with major thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: being younger than 18; having thalasemia major based on observing clinical symptoms and hemoglobin electrophoresis history; being treated by deferoxamine hypodermic injection and ferritin level 1000 to 3000. Exclusion:inability to digest exjade; hepatitis virologic; LFT; active hepatitis; noncompliance with previous treatment regimens; ALT and AST normal up to 3 times
Age
To 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
420/7/پ/9591
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Ferritin serum amount
Timepoint
at the beginning of the study and every 3 month for 6 months
Method of measurement
Using starfax device
Secondary outcomes
empty
Intervention groups
1
Description
The second group received exjade pills 20 mg/kg daily. Starfax device was used to measure ferritin serum at the beginning of the study and every 3 month during a 6-month period.
Category
Treatment - Drugs
2
Description
The first group received the normal treatment including 40 mg/kg deferoxamine hypodermic daily for 6 days a week. Starfax device was used to measure ferritin serum at the beginning of the study and every 3 month for 6 months.
Category
Treatment - Drugs
3
Description
The third group was treated with daily injection of 40 mg/kg of deferoxamine hypodermic 3 days a week and exjade pill 10mg/kg was taken simultaneously. Starfax device was used to measure ferritin serum at the beginning of the study and every 3 month during a 6-month period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Dr. Shadab Nazari
Street address
Mohammad Kermanshahi Hospital, Crossroads of Shirkhorshid
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshahu University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshahu 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Golpayegani
Position
Professor of Pediatric Hematology and Oncology
Other areas of specialty/work
Street address
Emamreza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6311
Fax
Email
mrgolpayegani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)