Haematological Disorders Paediatrics
Conditions
Interventions
placebo arm
Sponsors
Beni suef university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for enrollment at baseline were male or female aged between 6 and 18 years old with ß-Thalassemia major. Potential participants had been diagnosed with thalassemia major (TM), as confirmed by the presence of microcytic hypochromic anemia and hemoglobin electrophoresis; additionally, patients who had been receiving a regular blood transfusion during the last two years, with a serum ferritin (SF) level more than 1000 ng /ml were also considered.
Exclusion criteria
Exclusion criteria: Participants were excluded if they were more than 20 years old, their SF was less than 1000 ng /ml, they experienced heart failure (ejection fraction (EF) less than 30%), they were contraindicated to undergo the magnetic resonance imaging (MRI) scan, or they were expected to change their chelation therapy regimen during the next 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary trial endpoint was the change in the MIC and cardiac T2* after 6 months in either the placebo or treatment group. Efficacy data were analyzed as changes from core baseline to month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary trial endpoint were potential changes in the liver iron concentration , liver T2*, serum ferritin level , and left ventricle ejection fraction after 6 months of treatment in either group. | — |
Countries
Egypt
Contacts
Public ContactHoda Hagag
lecturer of clinical pharmacy faculty of pharmacy Beni suef university
Outcome results
None listed