A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)

Study Identifier:
A202305097
ClinicalTrials.gov Identifier:
NCT05981274
EudraCT Identifier:
N/A
Recruiting

Study Details

Medical Condition
  • Hemophilia A, Severe Without Inhibitor(s)
Study Drug
    Date
    Jul 2023 - Dec 2027
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: N/A years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Inclusion Criteria:
    • Patients with severe hemophilia A (all ages).
    • Patients with moderate type hemophilia A with hemophilic arthropathy.
    • Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year
    • Able and willing to undergo joint and bone examinations
    • Exclusion Criteria:
    • Participants of other interventional studies.
    • Patients with current inhibitors.
    • History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
    • History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
    • Significantly impaired vision/hearing

    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
    Tri-Service General Hospital Hemophilia Care Center
    Taipei, Neihu Dist., Taiwan, Province of China, 114202
    Status
    Recruiting