ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders

Study Identifier:
ATHN Transcends
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
American Thrombosis and Hemostasis Network
Collaborator:
Pfizer,Hemophilia of Georgia, Inc.,Genentech, Inc.,Hemab Therapeutics,CSL Behring,Sanofi,Novo Nordisk A/S
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Ignored
  • Hemophilia
  • Unmapped
  • Von Willebrand Disease
  • Platelet Disorder
  • Hemophilia B
  • Hemophilia A
Study Drug
    Date
    Sep 2020 - Jun 2035
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & 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
    Arizona Hemophilia and Thrombosis Treatment Center at Phoenix Children's Hospital
    Phoenix, Arizona, United States, 85016
    Status
    Recruiting
    Location
    Arkansas Center for Bleeding Disorders
    Little Rock, Arkansas, United States, 72202
    Status
    Recruiting
    Location
    Orthopaedic Institute for Children HTC
    Los Angeles, California, United States, 90007
    Status
    Recruiting
    Location
    Childrens Hospital Los Angeles
    Los Angeles, California, United States, 90027-6016
    Status
    Recruiting
    Location
    UCSF Benioff Children's Hospital Oakland
    Oakland, California, United States, 94610
    Status
    Recruiting
    Location
    University of California at Davis Hemophilia Treatment Center
    Sacramento, California, United States, 95817
    Status
    Recruiting