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

Prior treatment

• Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy;
• Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.

Other illness

• Have serious or poorly controlled chronic diseases or obvious systemic diseases;
• 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;
• The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
• When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
• Known or suspected hypersensitivity to any constituent of the trial product or related products;

Other

• 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);
• Ongoing or planned Immune Tolerance Induction treatment;

• Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and BMI \<28 kg/m\^2 at screening;
• The FVIII or FIX inhibitor test is positive at a high titer (≥5 BU/ml) during the screening period; or the FVIII or FIX inhibitor is detected at a low titer (0.6 BU/ml or the upper limit of normal value \< inhibitor titer \< 5 BU/ml) during the screening period and treatment with bypass agents (rFVIIa or PCC) has been started;
• ≥6 treated bleeding episodes within 26 weeks before screening;
• Have not used TFPI antibody drugs before;
• Be able and agree to elute prior drugs for the treatment of hemophilia.