Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Hormozgan University of Medical Sciences

Status: Completed

Conditions: Thalassemia; Transfusion Related Complications; Iron Overload

Treatments: Drug: osveral; Drug: Desferal

Study type: Interventional

Funder types: Other

Identifiers

NCT01369719

Desferal versus Osveral

Details and patient eligibility

About

Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.

Full description

This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.

Enrollment: 138 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed intermedia or major thalassemia
• More then 2 years old
• Serum Ferritin level > 1000
• Normal Creatinine and Complete Blood Count (CBC)

Exclusion criteria

• HCV, HBV or HIV positive patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Osveral

Experimental group

Description:

20 mg/kg oral osveral daily

Treatment:

Drug: osveral

desferal

Active Comparator group

Description:

40mg/kg desferal for 6 nights in a week subcutaneously

Treatment:

Drug: Desferal