Pharmacokinetic-guided Dosing of Emicizumab
Recruiting
Phase 4
Interventional Study
Hemophilia A With Inhibitor
Hemophilia A Without Inhibitor
Hemophilia A, Severe
Adolescent
Child
Adult
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 and older
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 95 (estimated)
- Sponsor
- Kathelijn Fischer · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 va…
Contacts