Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

Study Identifier:
GENA-25
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Octapharma
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
    Date
    Feb 2018 - Jun 2030
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    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
    Cure 4 The Kids Foundation Children's Specialty Center
    Las Vegas, Nevada, United States, 89109
    Status
    Withdrawn
    Location
    Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia
    Baku, Azerbaijan, AZ1012
    Status
    Withdrawn
    Location
    Republican Scientific Center for Radiation Medicine and Human Ecology
    Gomel, Belarus, 246040
    Status
    Withdrawn
    Location
    Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology
    Minsk, Belarus, 223053
    Status
    Recruiting
    Location
    Hôpital Universitaire des Enfants Reine Fabiola
    Brussels, Belgium, 1020
    Status
    Recruiting
    Location
    Cliniques Universitaires Saint-Luc
    Brussels, Belgium, 1200
    Status
    Recruiting