RecruitingPhase 3

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

China40 participantsStarted 2025-03-26

Plain-language 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

Age range12 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

12 hours effective hemostasis rate

Timeframe: 12 hours after the first administration

NCT IDNCT06922045

SponsorJiangsu BioJeTay Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Yanli Wang