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This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consecutive doses of low-dose of STSP-0601 | Experimental |
| |
| Consecutive doses of high-dose of STSP-0601 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSP-0601 for Injection | Drug | A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | From day 0 to up to day 8 | |
| Proportion of successfully treated bleeding episodes | 24 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of bleeding episodes with clinical relief of signs and symptoms | 4 hours、8 hours、24 hours after first administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, Ph.D | Hospital of Hematology, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Hematology, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41637644 | Derived | Liu W, Zhou H, Huang R, Du X, Wang P, Zhou Z, Zheng C, Lou S, Ma J, Song Y, Dai X, Wang X, Yang R, Zhang L. A specific FX activator for bleeding treatment in hemophilia with inhibitors: multicenter, open-label, phase 1/2 trials. Blood Adv. 2026 May 12;10(9):3002-3010. doi: 10.1182/bloodadvances.2025019486. | |
| 36796484 | Derived |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| STSP-0601 for Injection | Drug | A multiple-dose design to evaluate the safety,tolerability and efficacy of two doses of STSP-0601 for injection in patients with inhibitory hemophilia |
|
| Liu W, Xue F, Fu R, Ding B, Li M, Sun T, Chen Y, Liu X, Ju M, Dai X, Wu Q, Zhou Z, Yu J, Wang X, Zhu Q, Zhou H, Yang R, Zhang L. Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors. J Thromb Haemost. 2023 Jun;21(6):1453-1465. doi: 10.1016/j.jtha.2023.01.040. Epub 2023 Feb 14. |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |