Pharmacokinetic-guided Dosing of Emicizumab
Recruiting now · Phase 4
Conditions studied: Hemophilia A With Inhibitor, Hemophilia A Without Inhibitor, Hemophilia A, Severe, Adolescent, Child, Adult
In brief
The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients.
Key facts
- Study ID
- NCT06320626
- Run by
- Kathelijn Fischer
- People needed
- 95
- Starts
- 2022-09-08
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-03-20
Who can join
Age: 1 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of congenital haemophilia A, with a baseline endogenous FVIII of <6 IU/ml
- Aged > 1 year at inclusion (inclusion of children 1-16 years after favourable interim-analysis see protocol)
- 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
You may not qualify if…
- Acquired haemophilia A
Where it is running
- Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (enrolling)
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (enrolling)
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (enrolling)
- Leids Universitair Medisch Centrum — Leiden, South Holland, Netherlands (enrolling)
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (enrolling)
- HagaZiekenhuis — The Hague, South Holland, Netherlands (enrolling)
- University Medical Center Groningen — Groningen, Netherlands (enrolling)
- University Medical Center Utrecht — Utrecht, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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