Iron Overload, Thalassemia, Transfusion Related Complications
Conditions
Keywords
Thalassemia, Iron overload, transfusion, osveral, desferal
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.
Interventions
DRUGosveral
receive 20 mg/kg daily orally
DRUGDesferal
40-50mg/Kg for 6 nights in each week subcutaneously
Sponsors
Hormozgan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ferritin level | 8 months | ferritin level in months 4 and 8 of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin level | 8 month | hemoglobin level at months 4 and 8 off the study. |
| Drug side effects | 8 months | Leuckopenia, thrombocytopenia |
Countries
Iran
Outcome results
None listed