A Study to Learn More About Treatment With Damoctocog Alfa Pegol, How it is Used in Every Day Practice ("Real-World"), and How Satisfied People Who Receive Damoctocog Alfa Pegol Are in United States (US) Hemophilia Treatment Centers
Study Details
- Hemophilia A
- Male or female with a diagnosis of hemophilia A
- Previously or currently treated with damoctocog alfa pegol for at least 6 months.
- Treated with damoctocog alfa pegol per the US approved label to include:
- Aged ≥12 years at the time of damoctocog alfa pegol treatment initiation
- Previously treated for hemophilia A with an FVIII replacement therapy other than damoctocog alfa pegol
- Treatment modality of on-demand, prophylactic, intermittent prophylaxis or a combination thereof
- Have data in the medical record at the participating site as follows:
- For a minimum of 6 months prior to the damoctocog alfa pegol initiation date
- For a minimum of 6 months post-damoctocog alfa pegol initiation date AND the patient was receiving treatment with damoctocog alfa pegol during this 6-month follow-up period AND this data is dated prior to the central institutional review board (IRB) approval date for the study
- To include the FVIII replacement therapy most recently received prior to the initiation of damoctocog alfa pegol
- For patients in the prospective cohort
- Signed informed consent
- Current treatment with damoctocog alfa pegol or discontinued use of damoctocog alfa pegol within 3 months prior to the date of enrollment into the retrospective cohort.
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
- Participation in any past or current damoctocog alfa pegol interventional trial.
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.