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Recruiting
NCT05617209
In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients
Conditions: Hemophilia
Sex: Male
Ages: 12 Years – 65 Years
Enrollment: 20
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Location: France
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.
Eligibility Criteria
Inclusion Criteria:Severe or moderate haemophilia A or B patient with FVIII or FIX <5% with or without prophylaxisAffiliated or beneficiary of a social security regimenSignature of consentExclusion 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
Source: ClinicalTrials.gov (NCT05617209). StuddyBuddy aggregates publicly available trial information.