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

Last updated: November 26, 2024
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Completed

Phase

N/A

Condition

Hemophilia

Treatment

thrombin generation measurement

Clinical Study ID

NCT05617209
21CH036
  • Ages 12-65
  • Male

Study 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

Inclusion Criteria:

  • Severe or moderate haemophilia A or B patient with FVIII or FIX <5% with or withoutprophylaxis

  • Affiliated or beneficiary of a social security regimen

  • Signature of consent

Exclusion

Exclusion Criteria:

  • Haemophilia patients aged 12 years or less with a weight less than 30 kg (takinginto account the volume of blood collection).

  • Patients who received factor VIII concentrates less than 48 hours or factor IXconcentrates less than 96 hours prior to the routine blood draw at the HemophiliaClinic. 96 hours prior to the routine blood draw at the Hemophilia Centre

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: thrombin generation measurement
Phase:
Study Start date:
September 07, 2021
Estimated Completion Date:
January 05, 2023

Study Description

The aim of this study is to determine, for each patient, the minimum concentration of aTFPIAb necessary to restore thrombin generation in the presence of low (1pM) TF concentration and to evaluate at this concentration of aTFPIAb a potential thrombogenic effect in the presence of a high (10pM) TF concentration.

Connect with a study center

  • CHU Saint-Etienne

    Saint-Etienne, 42055
    France

    Site Not Available

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