?Exir research project of desferoxamin with brand name of Deferoxir

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2015012620818N1
• Date of registration: 2015-02-26
• Prospective Registration: No
• Primary sponsor: exir pharmacutical company
• Public title: ?Exir research project of desferoxamin with brand name of Deferoxir
• Scientific title: Comparison the efficacy of Deferoxir versus other desferoxamine products in thalassemia major patient
• Date of first enrolment: 2014-09-23
• Target sample size: 100
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/18398
• Study type: interventional
• Study design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr Mir Azizi
• Affiliation: Exir pharmacutical company

• Name: Dr Azarkeivan
• Affiliation: Iran blood transfusion center

Key inclusion & exclusion criteria

Inclusion 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.
Exclusion criteria:

Age minimum: 5 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

Cooley anaemia Severe beta thalassaemia Thalassaemia: intermedia major

thalassemia major.
Cooley anaemia Severe beta thalassaemia Thalassaemia: intermedia major

Intervention(s)

Deferoxir vial 500 mg,40 mg/kg,for 6 months.

Treatment - Drugs

Deferoxir vial 500 mg,40 mg/kg,for 6 months

Primary Outcome(s)

Ferritin. Timepoint: every 2 month from begining of study. Method of measurement: blood test.

Hgb. Timepoint: every 2 weeks from begining of study. Method of measurement: blood test.

WBC. Timepoint: every 2 weeks. Method of measurement: blood test.

Cr. Timepoint: every 2 month from begining of study. Method of measurement: blood test.

Platlet. Timepoint: every 2 weeks from begining of study. Method of measurement: blood test.

SGOT. Timepoint: every 2 month from begining of study. Method of measurement: blood test.

SGPT. Timepoint: every 2 month from begining of study. Method of measurement: blood test.

Secondary Outcome(s)

Optometry. Timepoint: before study,6 months after begining of study,12 months after beginig of study. Method of measurement: optometry.

Sonography. Timepoint: before study,6 months after begining of study,12 months after beginig of study. Method of measurement: Sonography.

T2*MRI. Timepoint: before study,6 months after begining of study,12 months after beginig of study. Method of measurement: blood test.

Audiology. Timepoint: before study,6 months after begining of study,12 months after beginig of study. Method of measurement: Audiology.

Source(s) of Monetary Support

exir pharmacutical company

Ethics review

Status: Approved
Approval date:
Contact:

institue of research and education of blood transfusion medicine