Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)

Study Identifier:
ANB-002-1
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Biocad
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia B
Study Drug
    Date
    May 2023 - Nov 2025
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 18+ 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
    Republican Scientific and Practical Center for Radiation Medicine and Human Ecology
    Gomel, Belarus, 246040
    Status
    Recruiting
    Location
    Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
    Minsk, Belarus, 220089
    Status
    Recruiting
    Location
    State Autonomous Institution for Healthcare "Chelyabinsk Regional Clinical Hospital"
    Chelyabinsk, Russian Federation, 454048
    Status
    Recruiting
    Location
    State budgetary healthcare institution Leningrad Regional Clinical Hospital
    Gatchina, Russian Federation, 188300
    Status
    Recruiting
    Location
    Kuzbass Clinical Hospital named after S.V. Belyaev
    Kemerovo, Russian Federation, 650066
    Status
    Recruiting
    Location
    Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
    Kirov, Russian Federation, 610027
    Status
    Recruiting