New shot could cut bleeding in Tough-to-Treat hemophilia

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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; 2. 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; 3. ≥6 treated bleeding episodes within 26 weeks before screening; 4. Have not used TFPI antibody drugs before; 5. Be able and agree to elute prior drugs for the treatment of hemophilia. 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.