Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload
Not Applicable
Completed
- Conditions
- ThalassemiaIron OverloadTransfusion Related Complications
- Interventions
- Drug: osveral
- Registration Number
- NCT01369719
- Lead Sponsor
- Hormozgan University of Medical Sciences
- Brief Summary
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.
- Detailed Description
This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Osveral osveral 20 mg/kg oral osveral daily desferal Desferal 40mg/kg desferal for 6 nights in a week subcutaneously
- Primary Outcome Measures
Name Time Method Ferritin level 8 months ferritin level in months 4 and 8 of the study
- Secondary Outcome Measures
Name Time Method Hemoglobin level 8 month hemoglobin level at months 4 and 8 off the study.
Drug side effects 8 months Leuckopenia, thrombocytopenia
Trial Locations
- Locations (1)
Hormozgan University of Medical Sciences (HUMS)
🇮🇷Bandar abbas, Hormozgan, Iran, Islamic Republic of