Objectives: To compare the effect of the combination and single use of exjade and desferal on ferritin levels in patients with thalassemia major. Design: This study is a clinical trial and has been carried out on patients with thalassemia major that treated with transfusion and regular subcutaneous injection Deferoxamine . Setting and conduct: patients are randomly divided into three groups, prescription drugs are given to each group and Serum ferritin will be measured before and after taking the drug, every 3 months up to 6 months. Participants: Patients with thalassemia major with hemoglobin electrophoresis test, prove to be ill and referred to Kermanshah thalassemia center and regularly treated with transfusion and subcutaneous injection by Deferoxamine. Interventions: the first group (control group) received a dose of 40 mg daily routine Deferoxamine per Kg of body weight subcutaneously, in the second group (Intervention group 1) therapy at a dose of 20 mg tablets exjade per kg in three divided doses with food and in the third group (Intervention group 2) received a dose of 40 mg daily routine Deferoxamine per Kg of body weight 3 days a week and Simultaneously receives exjade oral doses of 10 mg per kg 6 days a week. The main outcome variables: the amount of ferritin before the start of intervention, every 3 months to 6 months after taking the drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412097677N3
Registration date:2015-06-07, 1394/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-07, 1394/03/17
Registrant information
Name
Mohamadreza Golpayegani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6331
Email address
golpayegani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the efficacy of combination and single therapy of exjade and desferal on ferritin level in patients with major thalassemia
Public title
Effect of exjade on level in patients with thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Approved based on clinical symptoms and history of thalassemia and hemoglobin electrophoresis; full cooperation during the study; treatment with deferoxamine subcutaneous injection and ferritin levels below 3000. Exclusion criteria: Deferiprone gastrointestinal intolerance; leukocytes less than 3,000; severe liver disease; ascites; lack of consent, lack of cooperation in the history of previous treatment regimens (blood transfusion and deferoxamine).
Age
To 14 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)
Not 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 Ethics Committee
Street address
Kermanshah University of Medical Sciences- Shahid Beheshti Bolvar- Kermanshah
City
Kermanshah
Postal code
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
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
Serum ferritin level
Timepoint
Before the intervention; three months after the intervention and six months after intervention
Method of measurement
Based on the results of test ferritin
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Exjade; Novartis plant in France; tablets 20 mg per kg body weight; 3 times a day for 6 months
Category
Treatment - Drugs
2
Description
Intervention group2: Deferoxamine and Exjade; Novartis plant in France; Deferoxamine subcutaneous 40 mg per kg of body weight and tablet Exjade dose of 10 mg per kg of body weight; Deferoxamine once a two days and tablet Exjade once a day for 6 month
Category
Treatment - Drugs
3
Description
Control group:Deferoxamine; Novartis plant in France; subcutaneous 40 mg per kg body weight; once daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mohammad Kermanshahi Hospital
Full name of responsible person
Mohammad Reza Golpayegani
Street address
Department of Pediatric, Mohammad Kermanshahi Hospital, HelalAhmar, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Shahidbeheshti Bolvar
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah university of medical sciences
Full name of responsible person
Reza Akramipour
Position
Chief of Department of Pediatrics
Other areas of specialty/work
Street address
Mohammad Kemanshahi Hospital, Helal Ahmar Ave
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
Akramipur20@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadreza Golpayegani
Position
oncology of Children
Other areas of specialty/work
Street address
Mohammad Kemanshahi Hospital, Helal Ahmar Ave
City
Kermanshah
Postal code
Phone
+98 83 3721 8202
Fax
Email
golpayegani@kums.ac.ir, mrgolpayegani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shadab Nazari
Position
Resident of Pediatric
Other areas of specialty/work
Street address
Mohammad Kemanshahi Hospital, Helal Ahmar Ave
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)