A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab
Study Details
- Hemophilia A With Inhibitor(s)
- Drug: Feiba
- Inclusion Criteria:
- Male patients with congenital hemophilia A of any severity and any age.
- History of high titer factor VIII inhibitor (Bethesda unit \>5)
- Currently prescribed bypassing agent therapy for bleed management.
- Current treatment with emicizumab for a minimum of 2 months without interruption.
- Exclusion Criteria:
- Active bleed requiring factor therapy at screening.
- Treatment with rFVIIa or aPCC 7 days prior to screening.
- Surgical procedure 14 days prior to screening.
- Current use of any medication other than emicizumab that could affect the coagulation system e.g. aspirin, anticoagulants, etc.
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.