Monitoring anti‑TFPI antibodies in adult men with severe hemophilia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.