Monitoring anti‑TFPI antibodies in adult men with severe hemophilia
Monitoring of Anti-TFPI in Hemophilia EUREKA
This project tests blood-based lab methods to monitor anti-TFPI antibodies in adult men with severe hemophilia who are on prophylaxis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 11 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | Marstacimab, emicizumab |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT07101926 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood samples from adult men with severe hemophilia A or B on prophylaxis, including those receiving marstacimab, to measure thrombin generation and related coagulation markers. Investigators will perform both in vitro spiking experiments and ex vivo analyses of patient samples, comparing assay reagents and biological materials (for example platelet-poor versus platelet-rich plasma) to better reflect anti‑TFPI mechanism of action. The aim is to optimize thrombin generation assay conditions to improve sensitivity for detecting the hemostatic effects of anti‑TFPI antibodies. Sampling is timed after specified washout periods for factor concentrates and includes additional tubes reserved for research testing.
Who should consider this trial
Good fit: Men aged 18 or older with severe hemophilia A (FVIII < 1%) or B (FIX ≤ 2%) who are on prophylaxis (including marstacimab) and can meet the study's washout and extra blood‑draw requirements.
Not a fit: Patients with other coagulation disorders, those unwilling to provide additional blood samples, or those who cannot comply with the required washout periods are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this work could provide a reliable laboratory assay to monitor anti‑TFPI therapies and help clinicians better judge treatment effect and bleeding risk.
How similar studies have performed: Assay optimization has previously improved monitoring for emicizumab, but routine laboratory monitoring of anti‑TFPI antibodies remains largely unvalidated clinically.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria : * \- Male Patient * 18 years old * severe hemophilia patients A or B (FVIII \< 1%,FIX\<=2%) * on prophylaxis with FVIII or IX concentrates after an adequate washout period of 48h for SHL FVIII molecules, at least 4 days for EHL-FVIII Fc and at least 10 days for EHL-FIX molecules. * On prophylaxis with Marstacimab * Willing to participate * Capable of following protocol procedures under investigator appreciation * Exclusion Criteria : * \- patients refusing to provide 4 additional blood tubes for research * Patient with an other coagulation disorder * patients who received an injection of FVIII or FIX during the required washout period
Where this trial is running
Bron and 1 other locations
- Groupement hospitalier Est Hôpital Cardilogique Service d'hémostase clinique — Bron, France (Recruiting)
- Centre de Référence Hémophilie et autres déficits rares en protéine de la coagulationCentre de Traitemendes Hémophiles F. Josso — Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Yesim DARGAUD, Pr
- Email: gamze.dargaud@chu-lyon.fr
- Phone: 0472118822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.