Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor
Study Details
- Hemophilia
- Drug: STSP-0601 for Injection
- 18 ≤age≤70 years of age,male;
- Hemophilia A or B patients;
- A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);
- Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;
- There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);
- Establish proper venous access;
- Agree to use adequate contraception to avoid pregnancy;
- Provide signed informed consent.
- Have any coagulation disorder other than hemophilia;
- Plan to receive prophylactic treatment of coagulation factor during the trail;
- 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab during the trial;
- Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial;
- Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment;
- Have a history of arterial and/or venous thrombotic events;
- Platelet <100×109/L;
- Hemoglobin<90g/L;
- Severe liver or kidney disease;
- Severe bleeding event occurred within 4 weeks before enrollment;
- Accepted major operation or blood transfusion within 4 weeks before enrollment;
- HIV positive;
- Have a known allergy to STSP-0601;
- Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails);
- Patients not suitable for the trail according to the judgment of the investigators.
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.