A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
Study Details
- Hemophilia
- Drug: STSP-0601 for Injection
- 18 years old ≤age≤65 years of age,male.
- Hemophilia A or B patients with inhibitors.
- Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- Agree to use adequate contraception to avoid pregnancy.
- Provide signed informed consent.
- Have any coagulation disorder other than hemophilia A or B.
- Treat with prophylactic treatment of coagulation factor.
- Treat with anticoagulant within 7d of the time of study drug administration.
- Have a history of arterial and/or venous thromboembolic events.
- Have platelet <100,000/mL,hemoglobin<90g/L.
- Severe liver or kidney disease.
- Bleeding in the central nervous system or throat before screening.
- Accept major operation or blood transfusion within 1 month of the time of screening.
- HIV positive with current CD4+ count of less than 200/μl.
- Have a known allergy to Blood product.
- Participate in other clinical research within 1 month of the time of study drug administration.
- Treat with coagulant within 7d of the time of study drug administration.
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.