Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Hormozgan University of Medical Sciences138 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

138

Conditions

Thalassemia Iron Overload Transfusion Related Complications

Interventions

osveralDRUG

receive 20 mg/kg daily orally

DesferalDRUG

40-50mg/Kg for 6 nights in each week subcutaneously

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, Iran

Outcomes

Primary Outcomes

Ferritin level

ferritin level in months 4 and 8 of the study

Time frame: 8 months

Secondary Outcomes

Hemoglobin level

hemoglobin level at months 4 and 8 off the study.

Time frame: 8 month

Drug side effects

Leuckopenia, thrombocytopenia

Time frame: 8 months

Data from ClinicalTrials.gov

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