Children with thalassemia disease,
Conditions
Interventions
A liquid formulation of deferiprone
Children with thalassemia disease,
age equal to or more than two years of age
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
2 Years to 12 Years
Inclusion criteria
Inclusion criteria: Male & female age minimum 2 years, maximum 12 years
Exclusion criteria
Exclusion criteria: 1. Patients exhibit an anaphylaxis to deferriprone 2. Iron overload from other causes 3. Serum ferritin >7,000 ng/ml 4. ALT > 250 IU/L 5. Elevated creatinine for age 6. Absolute neutrophil <500/uL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile of a liquid formulation of deferiprone (GPO-L-ONE) Monthly Number of neutrophil | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of a liquid formulation of deferiprone (GPO-L-ONE) Monthly Declination of serum ferritin >15% from baseline | — |
Countries
Thailand
Contacts
Public ContactAmpaiwan Chuansumrit
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed