Tests dosing emicizumab based on drug levels in people with haemophilia A
Compares individualized emicizumab dosing with standard dosing in people with haemophilia A.
Plain-language title generated from the registry record
Registry title: Pharmacokinetic-guided dosing of emicizumab in congenital haemophilia A patients – The DosEmi study
Key facts
- Where
- 's-Gravenhage, Amsterdam, Groningen, Leiden, Maastricht, Nijmegen, Rotterdam, and Utrecht, NetherlandsSee the 8 sites
- Phase
- Phase 4
Where in Netherlands
- Haga Hospital's-Gravenhage, NetherlandsTaking people
- Stichting Amsterdam UMCAmsterdam, NetherlandsTaking people
- Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
- Stichting Radboud Universitair Medisch CentrumNijmegen, NetherlandsTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
- Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Medisch Centrum Utrecht
- Trial code
- NCT06320626EU 2024-515528-35-00
- Record updated
- 11 February 2026
- Original description
To determine whether individualized pharmacokinetic (PK)-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of treated bleeds, spontaneous joint- or muscle bleeds, and overall bleeding in patients with congenital haemophilia A.Read full original descriptionShow less
Pharmacokinetic-guided dosing of emicizumab in congenital haemophilia A patients – The DosEmi study
To determine whether individualized pharmacokinetic (PK)-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of treated bleeds, spontaneous joint- or muscle bleeds, and overall bleeding in patients with congenital haemophilia A.
Inclusion: Confirmed diagnosis of congenital haemophilia A, with a baseline endogenous FVIII of <6 IU/mL; Aged > 1 year at inclusion; Receiving conventional dosing of emicizumab (6 mg/kg/4 weeks with varying intervals) for a duration of at least 12 months prior to inclusion; Having good bleeding control, defined as: i. No spontaneous joint/muscle bleeds in the previous 6 months AND ii. A maximum of two treated (traumatic) bleeds in the previous 6 months; Willing and able to provide written informed consent, either by the subject or its parents/legal guardian; Willing to provide bleeding assessment information; Willing to adhere to the medication regimen.
Exclusion: Acquired haemophilia A.