bleeding disorder coagulation disorder
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age 6 years and older - Previously confirmed diagnosis of moderate or severe hemophilia A - Switch to a different FVIII concentrate in 2017 Possible switches: 1: plasma derived FVIII (pd-FVIII) product to recombinant FVIII (rFVIII) product 2: rFVIII to a different rFVIII product 3: pd-FVIII to rFVIII-Fc (fusion protein with a prolonged half-life, consisting of rFVIII and Fc-protien) 4: rFVIII to rFVIII-Fc;- Willing and be able to understand the study information and sign the informed consent form. In case of minor patients, this will be done by a proxy.
Exclusion criteria
Exclusion criteria: - Documented history of persisting severe anemia (defined as hemoglobin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in immunologic profile after switch to a different FVIII product, ie analysis of (FVIII specific) B- and T-cell subtypes, amount and function of regulatory T cells (Tregs) and cytokine production. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of inhibitor formation during first year after switch to a different factor VIII product. Comparison between the four different switches: - Switch of pd-FVIII to rFVIII - Switch of rFVIII to other type of rFVII - Switch of pd-FVIII to rFVIII-Fc - Switch of rFVIII to rFVIII-Fc | — |
Countries
The Netherlands
Outcome results
None listed