CompletedNot Applicable

In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients

France20 participantsStarted 2021-09-07

Plain-language summary

Studies have shown, in haemophilia patients, the effectiveness of Anti TFPI antibody (aTFPIAb) to prevent joint and muscular bleeding (tissues poor in Tissue Factor (TF)). However, cases of cerebral thrombosis (tissues rich in TF) have been observed in some patients treated with this antibody. Because an inter-individual variation in thrombin generation correction by aTFPIAb, an aTFPIAb concentration effective at low TF concentration could be at the same time thrombogenic at high TF concentration.

Who can participate

Age range12 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Severe or moderate haemophilia A or B patient with FVIII or FIX \<5% with or without prophylaxis * Affiliated or beneficiary of a social security regimen * Signature of consent Exclusion Criteria: * Haemophilia patients aged 12 years or less with a weight less than 30 kg (taking into account the volume of blood collection). * Patients who received factor VIII concentrates less than 48 hours or factor IX concentrates less than 96 hours prior to the routine blood draw at the Hemophilia Clinic. 96 hours prior to the routine blood draw at the Hemophilia Centre

What they're measuring

minimum concentration of anti-TFPI antibody

Timeframe: day 1

Trial details

NCT IDNCT05617209

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-05

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