Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors

Exclusion Criteria

• •1. Have serious or poorly controlled chronic diseases or obvious systemic diseases;
• •2. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy;
• •3. Have high-risk factors for thrombosis: such as a history of coronary atherosclerotic disease, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter;
• •4. The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
• •5. Being on standard prophylaxis and maintaining it for more than 12 weeks (standard prophylaxis is defined as at least 80% compliance with a predetermined prophylaxis regimen);
• •6. Ongoing or planned Immune Tolerance Induction treatment;
• •7. When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
• •8. Known or suspected hypersensitivity to any constituent of the trial product or related products;
• •9. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.