Pharmacokinetic-guided Dosing of Emicizumab

Study Identifier:
22-571
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Kathelijn Fischer
Collaborator:
Erasmus Medical Center,Amsterdam University Medical Center,Leiden University Medical Center,Radboud University Medical Center,Maastricht University Medical Center,University Medical Center Groningen,HagaZiekenhuis,Dutch Society of Haemophilia Patients
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A With Inhibitor(s)
  • Hemophilia A Without Inhibitor(s)
  • Hemophilia A, Severe
  • Unmapped
Study Drug
    Date
    Sep 2022 - Mar 2026
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 1+ years 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
    Radboud University Medical Center
    Nijmegen, Gelderland, Netherlands, 6525 GA
    Status
    Recruiting
    Location
    Maastricht University Medical Center
    Maastricht, Limburg, Netherlands
    Status
    Recruiting
    Location
    Amsterdam University Medical Center
    Amsterdam, Noord-Holland, Netherlands, 1105 AZ
    Status
    Recruiting
    Location
    HagaZiekenhuis
    Den Haag, Zuid-Holland, Netherlands, 2545 CH
    Status
    Recruiting
    Location
    Leids Universitair Medisch Centrum
    Leiden, Zuid-Holland, Netherlands, 2300 RC
    Status
    Recruiting
    Location
    Erasmus University Medical Center
    Rotterdam, Zuid-Holland, Netherlands, 3000CA
    Status
    Recruiting