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Pharmacokinetic-guided Dosing of Emicizumab
Sponsor: Kathelijn Fischer
Summary
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.
Official title: Pharmacokinetic-guided Dosing of Emicizumab in Congenital Haemophilia A Patients - The DosEmi Study
Key Details
Gender
MALE
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
95
Start Date
2022-09-08
Completion Date
2026-08
Last Updated
2024-03-20
Healthy Volunteers
No
Conditions
Interventions
Emicizumab - PK-guided dose reduction
PK-guided dose reduction emicizumab targeted at a Ctrough of 30μg/mL.
Emicizumab - Dosis continuation group
Continue on their current dose regimen
Emicizumab - Dose adjustment group
Adjusted in dosing regimen according to local protocol
Locations (8)
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
HagaZiekenhuis
The Hague, South Holland, Netherlands
University Medical Center Groningen
Groningen, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands