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

Launched by JIANGSU BIOJETAY BIOTECHNOLOGY CO., LTD. · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called STSP-0601 for patients with hemophilia A or B who have developed inhibitors—these are antibodies that can make standard treatments less effective. The trial aims to see how well multiple doses of STSP-0601 can help manage bleeding episodes in these patients. Right now, the study is looking for participants aged between 12 and 70 who have a history of bleeding events and meet other specific criteria, such as having a certain level of inhibitors in their blood.

If you or a family member are considering joining this trial, you'll need to agree to use contraception if there’s a chance of pregnancy and provide informed consent. Participants will be monitored closely throughout the study, but it's important to note that certain conditions, like other bleeding disorders or recent treatments, might prevent someone from being eligible. This trial could be an important opportunity for those struggling with hemophilia and facing challenges due to inhibitors.

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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.