A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Prophylaxis With Standard of Care Factor IX Protein (FIX) Replacement Therapy

Study Identifier:
R0000-HEMB-2187
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia B
Study Drug
    Date
    Jan 2024 - Apr 2026
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 16+ 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
    Orthopaedic Hemophilia Treatment Center
    Los Angeles, California, United States, 90007
    Status
    Recruiting
    Location
    University of Colorado Hemophilia and Thrombosis Center
    Aurora, Colorado, United States, 80045
    Status
    Recruiting
    Location
    Yale HTC
    New Haven, Connecticut, United States, 06520
    Status
    Recruiting
    Location
    Georgetown University Medical Center
    Washington, District of Columbia, United States, 20057
    Status
    Recruiting
    Location
    Rush University Medical Center
    Chicago, Illinois, United States, 60612
    Status
    Recruiting
    Location
    Indiana Hemophilia and Thrombosis Center
    Indianapolis, Indiana, United States, 46260
    Status
    Recruiting