A Study to Learn About the Study Medicine (Called Marstacimab) in People With Hemophilia A or B

Study Identifier:
B7841028
ClinicalTrials.gov Identifier:
NCT07859527
EudraCT Identifier:
N/A
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
  • Drug: Marstacimab
Date
Oct 2026 - Aug 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 6+ years years
Requirements Information
Inclusion and Exclusion Criteria
  • Medical record documentation of hematologist-confirmed diagnosis of hereditary factor VIII deficiency disease (Hemophilia A) or hereditary factor IX deficiency disease (Hemophilia B) prior to enrollment
  • Current treatment with marstacimab or documentation of a prescription to initiate marstacimab
  • Aged 6 or older at the time of consenting into the study
  • Receipt of medical care in the United States
  • Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally authorized representative) has been informed of all pertinent aspects of the study ○ If the participant is between the ages of 7 and 17, evidence of a personally signed and dated informed assent indicating that the participant has been informed of and assents to the study

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

No locations found.