Beta thalassemia. Beta thalassemia
Conditions
Interventions
Intervention 1: Intervention group 1: Iranian Deferasirox (Osveral®), dose 30 mg/kg/day, single daily dose, half an hour before breakfast, for 6 months, made by Osvah Pharmaceutical Company. Intervent
Sponsors
Sari University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: Male or female patients with ß-thalassemia major Age>2 year Ferritin level above 1000 mg/dL or the volume of blood transfusion above 100 mL/kg
Exclusion criteria
Exclusion criteria: Patients with pregnancy or breast-feeding state Progressive or persistent increase in the creatinine level Any cardiac, auditory or ophthalmic problems Hepatitis B (HBV) or C (HCV) and human immunodeficiency virus (HIV) infections Persistent liver transaminases above 5-fold of the normal level Severe nausea and vomiting Hypersensitivity to deferasirox Sever skin rashes Progressive proteinuria Non-compliant or unreliable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum ferritin concentration. Timepoint: bimonthly along 6 months. Method of measurement: Laboratory measurement of serum ferritin level. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes of cardiac and liver MRI T2*. Timepoint: Baseline and a year after starting of the treatments. Method of measurement: Measurement of T2* by Magnetic Resonance Imaging (MRI).;Drug safety and tolerability. Timepoint: Every two months to one year after treatment. Method of measurement: Question from patient and examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Mohammad Reza Rafati
Sari University of Medical Sciences
Outcome results
None listed