Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis
Study Details
- Hemophilia A
- Drug: Emicizumab
- Drug: FVIII
- Inclusion Criteria:
- Participant (if 18 years of age or older) or parent/LAR is willing and able to provide written informed consent; minor participant is willing and able to provide assent, if applicable based on site and local regulations
- Male participants with moderate to severe Hemophilia A ( FVIII activity \
- Participants must be on Emicizumab or standard FVIII prophylaxis per institutional/primary hematologist recommendations
- Participants must be engaging in sports activities with moderate to high risk of bleeding as defined by the NHF- Playing it Safe guidelines (numerical rating \>/= 2).
- Participants must be compliant with completing all standard of care bleed and treatment logs
- Participant must be willing to keep daily activity logs for the duration of the study.
- Exclusion Criteria:
- Participant/parent/LAR unwilling to provide informed consent/assent
- Unwilling to log or document bleeds and treatment information as per study guidelines
- Participants with any other bleeding disorders will be excluded
- Participants on concomittent FVIII replacement and emicizumab for sports participation
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.