A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER 4)
Status:
Not yet recruiting
Trial end date:
2028-04-28
Target enrollment:
Participant gender:
Summary
This study is looking at how Mim8 works in people with haemophilia A, who either have
inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid
bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII
(FVIII). When and how often the participants will receive Mim8 in this study depends on the
treatment participant receives in the current Mim8 study participant is taking part in. The
study will last for up to 5.5 years. The duration of the study depends on when the
participant enrolled in this study. The study will end if Mim8 is approved and marketed in
participant's country during the study, or the study will end in 2028, whichever comes first.
Mim8 will be injected under the skin with a thin needle either once a week, once every two
weeks or once a month. Participants will get up to 262 injections; the number of injections
depends on how often participants will get injections. While taking part in this study, there
are some restrictions about what medicine participants 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.