This study aims to compare and evaluate the efficacy and side effects of Defroxir with other valid deferoxamine mesilate products of Iran pharmaceutical industries. This is a multicenter, Before-After study on 100 patients (25 subjecta in each center) undergoing one of the stable valid deferoxamine products such as (desfral,desfonac,desferoxamine and etc…).Eligible participants include major thalassemic patients under regular blood injection therapy over 5 years old. After the first 6 months, every 25 patients under treatment with one of the stable valid deferoxamine products passing the wash out period and change to second phase including treatment with Defroxir therapy.
The measurements will be tested in month 0 (start of first phase treatment ), month 6 (change in treatment ) and month 12 ( end of treatment ). The mean change of repeated measurement will be considered as efficacy results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012620818N1
Registration date:2015-02-26, 1393/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-26, 1393/12/07
Registrant information
Name
Narges Jowzi
Name of organization / entity
Exir pharmacutical company
Country
Iran (Islamic Republic of)
Phone
+98 88918467
Email address
info@exir.co.ir
Recruitment status
Recruitment complete
Funding source
Exir pharmacutical company
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Deferoxir versus other desferoxamine products in thalassemia major patient
Public title
ٍExir research project of desferoxamin with brand name of Deferoxir
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with major thalassemia under regular blood injection therapy;. age over 5; undergoing treatment with one of deferoxamine pharmaceutical products; Norma renal function; serum cratinine undr 0. 7; in children under the age of 12 less than 1.0; in teenagers less than 1.1; and in over 16 years old pateinets (female less than 1.2; male less than 1.2); Trans aminase enzymes level less than 2 times of normal range; BUN<22mg/dl.
Exclusion Criteria: Any experience of allergic reaction to desferoxamine, positive HCV Ab / HBS Ag.
Age
From 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institue of research and education of blood transfusion medicine