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

Study Identifier:
21CH036
ClinicalTrials.gov Identifier:
NCT05617209
EudraCT Identifier:
N/A
Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
    Date
    Sep 2021 - Dec 2023
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 12 - 65 Years years
    Requirements Information
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

    Trial Locations

    Location
    Status
    Location
    CHU Saint-Etienne
    Saint-Etienne, France, 42055
    Status
    Recruiting