The efficacy of Iranian Deferasirox (Osveral®) and Exjade® in the treatment of patients with major beta-thalassemia
Phase 4
- Conditions
- Beta thalassemia.Beta thalassemia
- Registration Number
- IRCT20090813002342N9
- Lead Sponsor
- Sari University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in serum ferritin concentration. Timepoint: bimonthly along 6 months. Method of measurement: Laboratory measurement of serum ferritin level.
- Secondary Outcome Measures
Name Time Method 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.