Thalassemia Clinical Trial
Official title:
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas
Verified date | January 2010 |
Source | Hormozgan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | May 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Hormozgan University of Medical Sciences (HUMS) | Bandar abbas | Hormozgan |
Lead Sponsor | Collaborator |
---|---|
Hormozgan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ferritin level | ferritin level in months 4 and 8 of the study | 8 months | No |
Secondary | Hemoglobin level | hemoglobin level at months 4 and 8 off the study. | 8 month | No |
Secondary | Drug side effects | Leuckopenia, thrombocytopenia | 8 months | Yes |
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