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

Staidson Biopharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hemophilia

Treatments

Drug: STSP-0601 for Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05027230

STSP-0601-02

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.