Evaluation of the Safety and Efficacy of Hemophilia B Gene Therapy Drug

Study Identifier:
BBM001-CLN1001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Shanghai Belief-Delivery BioMed Co., Ltd
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia B
Study Drug
    Date
    Dec 2021 - Apr 2024
    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
    Anhui Provincial Hospital
    Hefei, Anhui, China, 230022
    Status
    N/A
    Location
    Peking Union Medical College Hospital
    Beijing, Beijing, China, 100005
    Status
    N/A
    Location
    Nanfang Hospital Southern Medical University
    Guangzhou, Guangdong, China, 510515
    Status
    N/A
    Location
    The Second People's Hospital of Shenzhen
    Shenzhen, Guangdong, China, 518025
    Status
    N/A
    Location
    North China University of Science and Technology Affiliated Hospital
    Tangshan, Hebei, China, 063000
    Status
    N/A
    Location
    Henan Cancer Hospital
    Zhengzhou, Henan, China, 450003
    Status
    N/A