NCT06320626 Pharmacokinetic-guided Dosing of Emicizumab
| NCT ID | NCT06320626 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kathelijn Fischer |
| Condition | Hemophilia A With Inhibitor |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2022-09-08 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 95 participants in total. It began in 2022-09-08 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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 Exclusion Criteria: * Acquired haemophilia A
Contact & Investigator
Study Officials Fischer, Dr, MD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT06320626 clinical trial?
This trial is open to male participants only, aged 1 Year or older, studying Hemophilia A With Inhibitor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06320626 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06320626 currently recruiting?
Yes, NCT06320626 is actively recruiting participants. Contact the research team at k.fischer@umcutrecht.nl for enrollment information.
Where is the NCT06320626 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Maastricht, Netherlands, Amsterdam, Netherlands, Leiden, Netherlands and 4 additional locations.
Who is sponsoring the NCT06320626 clinical trial?
NCT06320626 is sponsored by Kathelijn Fischer. The principal investigator is Study Officials Fischer, Dr, MD at UMC Utrecht. The trial plans to enroll 95 participants.