The European Paediatric Network for Haemophilia Management ( PedNet Registry)

Study Identifier:
Version 6.0 May 2020
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
PedNet Haemophilia Research Foundation
Collaborator:
Lund University Hospital
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
  • Hemophilia B
Study Drug
    Date
    Jun 2014 - Dec 2029
    Patient Requirements
    Sex: Female & 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
    Universitäts-Klinik für Kinder- und Jugendheilkunde
    Graz, Austria, A-8036
    Status
    Completed
    Location
    Medical University of Vienna - Department of Paediatrics
    Vienna, Austria
    Status
    Recruiting
    Location
    Service of Pediatric Haematology University Hospital Leuven
    Leuven, Belgium, B-3000
    Status
    Recruiting
    Location
    Division of Hematology/Oncology Hôpital St Justine
    Montréal, Canada, H3T 1C5
    Status
    Recruiting
    Location
    Division of Haematology/Oncology Hospital for Sick Children
    Toronto, Canada, M5G-1X8
    Status
    Recruiting
    Location
    Haemophilia Comprehensive Care Centre, Centre for Thrombosis and Haemostasis Children's University Hospital Brno
    Brno, Czech Republic, 613 00
    Status
    Recruiting