NCT07101926Recruiting
Monitoring of Anti-TFPI in Hemophilia
Monitoring of Anti-TFPI in Hemophilia EUREKA
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
During the development of anti-TFPI antibodies, thrombin generation assay (TGA) was employed using both in vitro measurements (antibodies added to blood samples) and ex vivo approaches (blood samples from patients in phase II and III trials). While a significant improvement in thrombin generation was observed in all samples from patients with severe hemophilia, no correlation with clinical outcomes could be established. Notably, thrombin peak levels were consistently improved even in patients who experienced bleeding episodes. These measurements were conducted in platelet-poor plasma (PPP) with standard reagents, which may not adequately reflect the hemostatic efficacy of anti-TFPI antibodies given their mechanism of action. It is hypothesized that optimizing reagents and utilizing more appropriate biological materials could enhance TGA sensitivity, as previously demonstrated for monitoring emicizumab. The absence of a laboratory assay to monitor anti-TFPI (tissue factor pathway inhibitor) antibodies poses a significant challenge for managing patients in surgical settings and treating acute severe bleeding. This study aims to develop a reliable assay to evaluate the hemostatic efficacy of anti-TFPI antibodies and their combined procoagulant effect with factor concentrates (FVIII or FIX) or bypassing agents.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 11 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 23 Oct 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Haemophilia
- NCT number
- NCT07101926
What you commit to
- Study type: Observational
- Planned participants: 11
- From 23 Oct 2025 to the primary completion date, Aug 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Groupement hospitalier Est Hôpital Cardilogique Service d'hémostase clinique Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre de Référence Hémophilie et autres déficits rares en protéine de la coagulationCentre de Traitemendes Hémophiles F. Josso Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.