A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate
Study Details
- Hemophilia A
- Inclusion Criteria:
- Participants with severe hemophilia A.
- All age groups (less than [<] 12 and greater than [>] 12 years of age).
- Participant with greater than equal to (>=) 150 documented exposure days (EDs).
- Treated with Adynovate:
- Having a PK analysis done/data available for post-hoc modeling
- Having recorded clinical outcomes analysis: for > 6 months
- Treated with a SHL/EHL-FVIII product for at least six months before switching to Adynovate
- To qualify for the secondary objective participants will need to have a WAPPS study performed on Adynovate and on the SHL/EHL-FVIII they were treated before switching.
- Exclusion Criteria:
- Any participant who meets any of the following criteria will not qualify for entry into the study:
- Participants with only on-demand Factor VIII (FVIII) use.
- Current presence of FVIII inhibitory antibodies. (Participants with a history of inhibitors, if any, will be considered for a sensitivity analysis).
- Diagnosis of other inherited or acquired hemostatic defect other than hemophilia A.
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.