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

Inclusion Criteria:

1. 12 ≤age≤70 years of age.

2. Hemophilia A or B patients.

3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.

4. Establish proper venous access.

5. There were at least 3 bleeding events that required treatment occurred in the past 6months before screening.

6. Agree to use adequate contraception to avoid pregnancy.

7. Provide signed informed consent.

Exclusion Criteria:

1. Have any coagulation disorder other than hemophilia.

2. Plan to receive prophylactic treatment of coagulation factor during the trail.

3. Patients plan to receive Emicizumab during the trial.

4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the firstadministration or plan to receive these drugs during the trial.

5. Have a history of arterial and/or venous thrombotic events.

6. Platelet <100×109/L.

7. Hemoglobin<90g/L.

8. Severe liver or kidney disease.

9. Severe bleeding event occurred within 4 weeks before the first administration.

10. Accepted major operation or blood transfusion within 4 weeks before the firstadministration.

11. Have a known allergy to STSP-0601.

12. Pregnant, lactating, or blood pregnancy test positive female subjects

13. Participate in other clinical research within 4 weeks before enrollment (except forparticipating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).

14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, andaminocaproic acid were used. Within 3 days before the first administration,prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment withEmicizumab was received.

15. Patients not suitable for the trail according to the judgment of the investigators.