Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

Study Identifier:
CSL222_3003
ClinicalTrials.gov Identifier:
NCT05962398
EudraCT Identifier:
N/A
Sponsor:
CSL Behring
Collaborator:
N/A
Study Contact Information:
N/A
Recruiting

Study Details

Medical Condition
  • Hemophilia B
Study Drug
    Date
    Aug 2023 - Mar 2035
    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
    10-15 Phoenix Childrens Hospital
    Phoenix, Arizona, United States, 85016
    Status
    N/A
    Location
    10-14 Arkansas Children's Hospital - Pharmacology
    Little Rock, Arkansas, United States, 72202
    Status
    N/A
    Location
    10-22 Orthopaedic Institute for Children
    Los Angeles, California, United States, 90007
    Status
    N/A
    Location
    10-21 Children's Hospital of Los Angeles
    Los Angeles, California, United States, 90027
    Status
    N/A
    Location
    10-63 UC Davis Medical Center
    Sacramento, California, United States, 95817
    Status
    N/A
    Location
    10-12 University of California, San Diego (UCSD)
    San Diego, California, United States, 92121
    Status
    N/A