An Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A.
Study Details
- Hemophilia A
- Hemophilia
- Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)
- Inclusion Criteria:
- Diagnosis hemophilia A with FVIII:C ≤2%.
- Patients ≥ 18 years of age.
- Previously treated for hemophilia A (PTPs).
- Patients who had initiated damoctocog alfa pegol maximum 12 months prior to enrollment into the study or who initiate damoctocog alfa pegol treatment at the enrollment , where the decision to initiate damoctocog alfa pegol has been made before the decision for study participation.
- Patients having a HEAD-US measurement available in the 2 months prior to damoctocog alfa pegol treatment initiation.
- Patients without previous history of FVIII inhibitors or patients with previous history of FVIII inhibitors on standard prophylaxis therapy for at least 1 year prior to baseline (damoctocog alfa pegol treatment initiation).
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
- Signed informed consent/assent.
- Exclusion Criteria:
- Concurrent participation in an investigational program with interventions outside of routine clinical practice.
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
- Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
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.