Hemophilia
Conditions
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
Interventions
Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors
Sponsors
Jiangsu BioJeTay Biotechnology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 hours effective hemostasis rate | 12 hours after the first administration |
Secondary
| Measure | Time frame |
|---|---|
| Rescue treatment rate | Within 72 hours after the last administration |
| The time from the onset of bleeding to complete/significant relief | Within 72 hours after the last administration |
| The effective hemostasis rate of the target joint | From 12 hours after the first administration to 72 hours after the last administration |
| 8-hours excellent + good rate | 8 hours after the first administration |
| Complete + significant relief rate | 4 hours, 8 hours, 12 hours, 24 hours after the first administration |
| 8-hours effective hemostasis rate | 8 hours after the first administration |
| Effective hemostasis rate at the first 12 hours bleeding visit | 12 hours after the first administration |
| 12 hours excellent + good rate | 12 hours after the first administration |
| The number of medication required for effective hemostasis within 12 hours | 12 hours after the first administration |
| The time to achieve complete/significant remission after the first administration | From the time after the first administration until within 72 hours after the last administration |
| The amount of medication (U/kg) required for effective hemostasis within 12 hours | 12 hours after the first administration |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLei Zhang, Ph.D
Hospital of Hematology, Chinese Academy of Medical Sciences
Outcome results
None listed