Pharmacokinetic-guided Dosing of Emicizumab
NCT06320626 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2024-03-20
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.
Conditions
- Hemophilia A With Inhibitor
- Hemophilia A Without Inhibitor
- Hemophilia A, Severe
- Adolescent
- Child
- Adult
Interventions
- OTHER
-
Emicizumab - PK-guided dose reduction
PK-guided dose reduction emicizumab targeted at a Ctrough of 30μg/mL.
- OTHER
-
Emicizumab - Dosis continuation group
Continue on their current dose regimen
- OTHER
-
Emicizumab - Dose adjustment group
Adjusted in dosing regimen according to local protocol
Sponsors & Collaborators
- collaborator OTHER
-
Amsterdam University Medical Center
collaborator OTHER -
Leiden University Medical Center
collaborator OTHER -
Radboud University Medical Center
collaborator OTHER -
Maastricht University Medical Center
collaborator OTHER -
University Medical Center Groningen
collaborator OTHER -
HagaZiekenhuis
collaborator OTHER -
Dutch Society of Haemophilia Patients
collaborator UNKNOWN -
Kathelijn Fischer
lead OTHER
Principal Investigators
-
Study Officials Fischer, Dr, MD · UMC Utrecht
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 1 Year
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-08
- Primary Completion
- 2026-03-31
- Completion
- 2026-08-31
Countries
- Netherlands
Study Locations
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