Intra-Articular Bevacizumab for Preventing Recurrent Hemarthrosis in Hemophilia With Chronic Synovitis
Study Details
- Hemophilia
- Unmapped
- Drug: Intra-articular Bevacizumab
- Confirmed diagnosis of Hemophilia A.
- Presence of one or more target joints (knee, elbow, ankle) with chronic synovitis and a history of \>2 hemarthrosis episodes in the past 6 months.
- Target joint World Federation of Hemophilia (WFH) joint score of 2-3.
- Adequate hematological, renal, and liver function (as specified by protocol lab values).
- Ability and willingness to provide informed consent and comply with the study protocol.
- HIV positive diagnosis.
- Severely damaged joints or anatomical limitations preventing safe injection.
- Contraindications to MRI.
- Uncontrolled hypertension.
- Recent major surgery/trauma (\<28 days).
- Serious non-healing wound, active cardiovascular disease, or other significant comorbidities that could increase risk or interfere with the study.
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.