To assess compliance, efficacy and satisfaction with two different formulation of deferasirox in patients with transfusion-dependent beta-thalassemia
Phase 3
- Conditions
- Major Thalassaemia.Beta thalassaemia
- Registration Number
- IRCT2015101218603N2
- Lead Sponsor
- Vice chancellor of research, Shiaz Univeisity of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
signing informed consent; male or female aged = 2 years at screening; patients with transfusion dependent thalassemia major; regular transfusion indicated by a blood requirement = 8 blood transfusions per year at screening. Exclusion criteria: patients with mean levels of ALT above 5 fold the upper limit of normal (ULN); patients with serum creatinine above ULN; significant proteinuria as indicated by a urinary protein/creatinine ratio> 0.6 (mg/mg); creatinine clearance = 60 ml/min; chronic hepatitis B infection; active hepatitis C infection; pregnancy or breastfeeding; non-transfusion dependent thalassemia (NTDT)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients compliance and satisfaction. Timepoint: three months after drug consumption. Method of measurement: designed questionnaire for patient compliance and satisfaction assessing.
- Secondary Outcome Measures
Name Time Method Ferritin serum amount. Timepoint: at the beginning of the study and monthly for 3 months. Method of measurement: Using starfax device.;Safety. Timepoint: Base line, End of evey month for 3 months. Method of measurement: Follow up, clinical examination by expert hematologist.;Possible gastrointestinal side effects, including diarrhea, and dermatologic symptoms. Timepoint: Base line, End of every month for three months. Method of measurement: Follow up,clinical examination by expert hematologist.