| NCT ID | NCT07101926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Hemophilia |
| Study Type | OBSERVATIONAL |
| Enrollment | 11 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 11 participants in total. It began in 2025-10-23 with a primary completion date of 2026-08.
⚠ 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
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07101926 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07101926 currently recruiting?
Yes, NCT07101926 is actively recruiting participants. Contact the research team at gamze.dargaud@chu-lyon.fr for enrollment information.
Where is the NCT07101926 trial being conducted?
This trial is being conducted at Bron, France, Paris, France.
Who is sponsoring the NCT07101926 clinical trial?
NCT07101926 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 11 participants.