Actively Recruiting
Monitoring of Anti-TFPI in Hemophilia EUREKA
Led by Hospices Civils de Lyon · Updated on 2026-03-23
11
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating anti-TFPI (tissue factor pathway inhibitor) antibodies in patients with severe hemophilia A or B to develop a laboratory assay that better reflects their hemostatic effects. While previous tests showed improved thrombin generation in blood samples, these did not correlate well with clinical outcomes, especially for patients who still experienced bleeding. The study aims to improve testing methods by using optimized reagents and biological materials that could more accurately monitor these antibodies and their combined effects with factor concentrates or bypassing agents. Participants include adults with severe hemophilia A or B who are on prophylaxis with factor VIII or IX concentrates or marstacimab after appropriate washout periods. The main intervention is a one-time peripheral blood draw during a routine clinic visit for thrombin generation testing on different plasma types. No additional treatments or procedures are involved in this observational study. During the single study visit, blood samples will be analyzed to develop and assess the sensitivity of thrombin generation assays for anti-TFPI antibodies. Researchers will evaluate assay parameters, correlate lab results with clinical use of anti-TFPI therapies, and detect any hypercoagulability from combined treatments. This study provides important data on monitoring anti-TFPI therapies to better manage patients with severe hemophilia, with participation lasting only one visit.
CONDITIONS
Brief Title
Monitoring of Anti-TFPI in Hemophilia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patient
- At least 18 years old
- Diagnosed with severe hemophilia A or B (FVIII < 1%, FIX 2%)
- On prophylaxis with FVIII or FIX concentrates after an adequate washout period (48 hours for SHL FVIII, at least 4 days for EHL-FVIII Fc, at least 10 days for EHL-FIX)
- On prophylaxis with marstacimab
- Willing to participate
- Able to follow protocol procedures as judged by the investigator
You will not qualify if you...
- Refusal to provide 4 additional blood tubes for research
- Presence of another coagulation disorder
- Received an injection of FVIII or FIX during the required washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a one-time blood draw during a routine clinical visit for laboratory testing of anti-TFPI antibodies.
1 visit (in-person)
Duration - Ongoing after sample collection
Participants are observed to assess laboratory assay development and monitor coagulation parameters without additional medical procedures or treatments.
No additional visits required
Trial Site Locations
Total: 2 locations
1
Groupement hospitalier Est Hôpital Cardilogique Service d'hémostase clinique
Bron, France, 69677
Actively Recruiting
2
Centre de Référence Hémophilie et autres déficits rares en protéine de la coagulationCentre de Traitemendes Hémophiles F. Josso
Paris, France, 75015
Not Yet Recruiting
Research Team
Y
Yesim DARGAUD, Pr
S
Sandra DURANTEL
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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