Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor

A Multi-center, Open-label, Phase Ⅱb Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients with Hemophilia with Inhibitor

This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor.

Inclusion Criteria:

1. 18 ≤age≤70 years of age,male.
2. Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
3. Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
4. Establish proper venous access.
5. There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
6. Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
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 enrollment or plan to receive these drugs during the trial.Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment.
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 enrollment.
10. Accepted major operation or blood transfusion within 4 weeks before enrollment.
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 for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
14. Within 1 day prior to enrollment, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days prior to enrollment, prothrombin complex, FVIII, and FIX were used. Within 4 weeks prior to enrollment, treatment with amisulumab was received.
15. Patients not suitable for the trail according to the judgment of the investigators.