Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Collaborator: Beijing Novikang Medical Technology Co., LTD

Criteria

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);

• Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;

• There were at least 2 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 received prophylactic treatment of Emicizumab 4 weeks before screening or 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 <100×109/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;

• HIV positive;

• 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.