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

Staidson Biopharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Hemophilia

Treatments

Drug: STSP-0601 for Injection

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05619926

STSP-0601-03

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 the second stage is applicable);
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;
4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab 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.