A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI

Study Identifier:
HZRM_ObsITI_4th Am.Version
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Haemophilia Centre Rhine Main
Collaborator:
University of Bonn,Skane University Hospital,Hopital Cardiologique Louis Pradel, Unité d'Hemostase Clinique Bron
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
    Date
    Aug 2006 - Dec 2026
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: N/A - N/A years
    Requirements Information

    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
    Haemophilia Centre Rhine Main
    Frankfurt, Hessen, Germany, 60596
    Status
    Recruiting