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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2025-03-26 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Contact & Investigator
Lei Zhang, Ph.D
PRINCIPAL INVESTIGATOR
Hospital of Hematology, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06922045 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 70 Years, studying Hemophilia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06922045 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06922045 currently recruiting?
Yes, NCT06922045 is actively recruiting participants. Contact the research team at wangyanli@staidson.com for enrollment information.
Where is the NCT06922045 trial being conducted?
This trial is being conducted at Hefei, China, Lanzhou, China, Guangzhou, China, Shenzhen, China and 11 additional locations.
Who is sponsoring the NCT06922045 clinical trial?
NCT06922045 is sponsored by Jiangsu BioJeTay Biotechnology Co., Ltd.. The principal investigator is Lei Zhang, Ph.D at Hospital of Hematology, Chinese Academy of Medical Sciences. The trial plans to enroll 40 participants.