Status:
RECRUITING
Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
Lead Sponsor:
Jiangsu BioJeTay Biotechnology Co., Ltd.
Conditions:
Hemophilia
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- 12 ≤age≤70 years of age.
- Hemophilia A or B patients.
- Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
- Establish proper venous access.
- There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
- Agree to use adequate contraception to avoid pregnancy.
- Provide signed informed consent.
Exclusion
- Have any coagulation disorder other than hemophilia.
- Plan to receive prophylactic treatment of coagulation factor during the trail.
- Patients plan to receive Emicizumab during the trial.
- Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
- 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 the first administration.
- Accepted major operation or blood transfusion within 4 weeks before the first administration.
- Have a known allergy to STSP-0601.
- Pregnant, lactating, or blood pregnancy test positive female subjects
- Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
- 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.
- Patients not suitable for the trail according to the judgment of the investigators.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06922045
Start Date
March 26 2025
End Date
December 1 2026
Last Update
November 25 2025
Active Locations (18)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
Lanzhou University First Hospital
Lanzhou, Gansu, China, 730000
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
4
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518000