Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B 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.
- EligibilityCriteria: Inclusion Criteria:  18 ≤age≤70 years of age,male. Hemophilia A or B patients. A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage). Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled. 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). 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. 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 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. Have a history of arterial and/or venous thrombotic events. Platelet <100×10 9/L. Hemoglobin<90g/L. Severe liver or kidney disease. Severe bleeding event occurred within 4 weeks before enrollment. Accepted major operation or blood transfusion within 4 weeks before enrollment. Have a known allergy to STSP-0601. Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails). Patients not suitable for the trail according to the judgment of the investigators. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult