Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
Study Details
- Hemophilia A
- Hemophilia B
- Drug: Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures
- Drug: Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures
- Inclusion Criteria:
- patient with Haemophilia A or B
- surgery performed with Elocta® or Alprolix®
- Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors
- Exclusion Criteria:
- Any blood coagulation disorder other than Haemophilia A or B
- Patient with factor VIII or IX inhibitor
- Severe liver disease (serum ALAT/ASAT levels\> 5 x ULN)
- Severe renal disease (serum creatinine \> 2x ULN)
- Known hypersensitivity to the substances or its excipients
- patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)
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.