A Study of Standard and Individualized Prophylactic Treatment With Advate in Men and Boys With Severe Hemophilia A

Study Identifier:
TAK-761-4001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Takeda
Collaborator:
N/A
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Hemophilia A
Study Drug
    Date
    Aug 2021 - Feb 2023
    Patient Requirements
    Sex: 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
    City Children's Hospital No. 1
    Kazan, Tatarstan, Russian Federation, 420034
    Status
    N/A
    Location
    Chelyabinsk Regional Children's Clinical Hospital
    Chelyabinsk, Russian Federation, 454087
    Status
    N/A
    Location
    Children's Regional Clinical Hospital
    Khabarovsk, Russian Federation, 680003
    Status
    N/A
    Location
    Krasnoyarsk Regional Clinical Center for Maternal and Child Health
    Krasnoyarsk, Russian Federation, 660074
    Status
    N/A
    Location
    Morozovskaya Children's City Clinical Hospital of the Department of Healthcare of the city of Moscow
    Moscow, Russian Federation, 119049
    Status
    N/A
    Location
    State Budgetary Institution of Healthcare "Republican children's clinical hospital" of the Ministry of Health of the Kabardino-Balkar Republic
    Nalchik, Russian Federation, 360032
    Status
    N/A