NCT06922045 Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
| NCT ID | NCT06922045 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jiangsu BioJeTay Biotechnology Co., Ltd. |
| Condition | Hemophilia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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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 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