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

Launched by STAIDSON (BEIJING) BIOPHARMACEUTICALS CO., LTD · Aug 25, 2021

Keywords

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Gender

MALE

Eligibility criteria

• 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.