Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

Inclusion criteria

• 12 ≤age≤70 years of age.
• Hemophilia A or B patients.
• Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
• Establish proper venous access.
• There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
• Agree to use adequate contraception to avoid pregnancy.
• Provide signed informed consent.

Exclusion criteria

• Have any coagulation disorder other than hemophilia.
• Plan to receive prophylactic treatment of coagulation factor during the trail.
• Patients plan to receive Emicizumab during the trial.
• Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
• 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 the first administration.
• Accepted major operation or blood transfusion within 4 weeks before the first administration.
• Have a known allergy to STSP-0601.
• Pregnant, lactating, or blood pregnancy test positive female subjects
• Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
• Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
• Patients not suitable for the trail according to the judgment of the investigators.