Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

Jiangsu BioJeTay Biotechnology Co., Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Hemophilia

Treatments: Drug: STSP-0601 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06922045

STSP-0601-05

Details and patient eligibility

About

This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor

Enrollment: 32 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 12 ≤age≤70 years of age.
2. Hemophilia A or B patients.
3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
4. Establish proper venous access.
5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
6. Agree to use adequate contraception to avoid pregnancy.
7. Provide signed informed consent.

Exclusion criteria

1. Have any coagulation disorder other than hemophilia.
2. Plan to receive prophylactic treatment of coagulation factor during the trail.
3. Patients plan to receive Emicizumab during the trial.
4. Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
5. Have a history of arterial and/or venous thrombotic events.
6. Platelet <100×109/L.
7. Hemoglobin<90g/L.
8. Severe liver or kidney disease.
9. Severe bleeding event occurred within 4 weeks before the first administration.
10. Accepted major operation or blood transfusion within 4 weeks before the first administration.
11. Have a known allergy to STSP-0601.
12. Pregnant, lactating, or blood pregnancy test positive female subjects
13. Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
14. Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
15. Patients not suitable for the trail according to the judgment of the investigators.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Continuous administration of STSP-0601

Experimental group

Treatment:

Drug: STSP-0601 for Injection