NCT06320626RecruitingPhase 4
Pharmacokinetic-guided dosing of emicizumab in congenital haemophilia A patients – The DosEmi study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- First submitted
- 18 Jun 2024
- Start date
- 8 Sept 2022
- Lead sponsor
- Universitair Medisch Centrum Utrecht
- Diseases
- Haemophilia
- NCT number
- NCT06320626
- EU CT number
- 2024-515528-35-00
- EudraCT number
- 2021-004039-10
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 135
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- Acquired haemophilia A
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stichting Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Stichting Radboud Universitair Medisch Centrum Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Haga Hospital Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.