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

NCT ID: NCT05617209

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-07

Study Completion Date

2023-01-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemophilia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe and/or moderate haemophilia A and B

At the end of the consultation and follow-up of the disease, an additional blood sample of 35 ml (8 tubes) will be taken

thrombin generation measurement

Intervention Type OTHER

Thrombin generation will be measured in Platelets rich plasma induced either by 1 pM TF or 10 pM TF concentration in presence of different aTFPIAb concentrations (0; 0.5 µg/ml; 0.75 µg/ml; 1.0 µg/ml; 2.0 µg/ml; 4.0 µg/ml)

Interventions

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thrombin generation measurement

Thrombin generation will be measured in Platelets rich plasma induced either by 1 pM TF or 10 pM TF concentration in presence of different aTFPIAb concentrations (0; 0.5 µg/ml; 0.75 µg/ml; 1.0 µg/ml; 2.0 µg/ml; 4.0 µg/ml)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigitte Tardy, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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21CH036

Identifier Type: -

Identifier Source: org_study_id