Patient Preferences in Treatment of Haemophilia A With and Without Inhibitors: a Discrete Choice Experiment in Germany

Study Identifier:
DAS-8858
ClinicalTrials.gov Identifier:
NCT07653139
EudraCT Identifier:
N/A
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
    Date
    Jul 2026 - Oct 2026
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
    • Participant has the mental capacity and sufficient German language proficiency to understand the study procedures and to complete the survey.
    • Age above or equal to 18 years at the time of signing informed consent.
    • Validated diagnose with haemophilia A, with and without inhibitors.
    • Resident in Germany.
    Exclusion Criteria
    • No provision of informed consent in this study.
    • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
    • Age below 18 years at the time of signing informed consent.
    • Absence of a diagnosis of haemophilia A.
    • No residence in Germany.

    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
    Novo Nordisk Investigational Site
    Mainz, Gonsenheim, Germany, 55124
    Status
    N/A