Actively Recruiting
Pharmacokinetic-guided Dosing of Emicizumab
Led by Kathelijn Fischer · Updated on 2024-03-20
95
Participants Needed
8
Research Sites
203 weeks
Total Duration
On this page
Sponsors
K
Kathelijn Fischer
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pharmacokinetic-guided Dosing of Emicizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of congenital haemophilia A with baseline endogenous factor VIII below 6 IU/ml
- Age greater than 1 year at inclusion
- Receiving conventional emicizumab dosing for at least 12 months before joining
- Good bleeding control with no spontaneous joint or muscle bleeds in the last 6 months
- No more than two treated traumatic bleeds in the last 6 months
- Willing and able to provide written informed consent
- Willing to provide bleeding assessment information
- Willing to follow the medication regimen
You will not qualify if you...
- Diagnosis of acquired haemophilia A
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Actively Recruiting
3
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
4
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands, 2300 RC
Actively Recruiting
5
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3000CA
Actively Recruiting
6
HagaZiekenhuis
The Hague, South Holland, Netherlands, 2545 CH
Actively Recruiting
7
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Actively Recruiting
8
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
K
Kathelijn Fischer, Dr, MD.
CONTACT
K
Konrad VD van der Zwet, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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