A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

A Phase Ib/II,Multi-center, Open, Multiple-dose Design to Evaluate the Safety,Tolerability and Efficacy of STSP-0601 for Injection in Patients With Inhibitory Hemophilia

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 inhibitors.

Inclusion Criteria:

• 18 years old ≤age≤65 years of age,male.
• Hemophilia A or B patients with inhibitors.
• Received hemostatic treatment with investigational drug, or to undergo minor surgical or other invasive procedures (Only for phase 2. Minor surgical procedures: procedures without general anesthesia and the wounds are easy to observe).
• Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
• Establish proper venous access.
• Agree to use adequate contraception to avoid pregnancy.
• Provide signed informed consent.

Exclusion Criteria:

• Have any coagulation disorder other than hemophilia A or B.
• Treat with prophylactic treatment of coagulation factor.
• Treat with anticoagulant within 7d of the time of study drug administration.
• Have a history of arterial and/or venous thromboembolic events.
• Have platelet <100,000/mL,hemoglobin<90g/L.
• Severe liver or kidney disease.
• Bleeding in the central nervous system or throat before screening.
• Accept major operation or blood transfusion within 1 month of the time of screening.
• HIV positive with current CD4+ count of less than 200/μl.
• Have a known allergy to Blood product.
• Participate in other clinical research within 1 month of the time of study drug administration.
• Treat with coagulant within 7d of the time of study drug administration.