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Monitoring of Anti-TFPI in Hemophilia

Recruitingn/aAges 18 Years - anyAllHospices Civils de Lyon
NCT07101926 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 monitor

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📋 Eligibility rules (as published)
* 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
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What it tests

  • blood sampling
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Where

2 sites
Groupement hospitalier Est Hôpital Cardilogique Service d'hémostase clinique
Bron, France
Centre de Référence Hémophilie et autres déficits rares en protéine de la coagulationCentre de Traitemendes Hémophiles F. Josso
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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