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| Name | Class |
|---|---|
| Beijing Novikang Medical Technology Co., LTD | UNKNOWN |
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This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
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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 | Intravenous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | From day 0 to up to day 4 | |
| Proportion of successfully treated bleeding episodes | 8 hours after first administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of successfully treated bleeding episodes | 12 hours,24 hours after first administration of study drug | |
| Proportion of bleeding episodes received salvage treatment | Within 3 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, MD | Affiliation:Hospital of Hematology, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China | ||
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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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| Lanzhou University First Hospita |
| Lanzhou |
| Gansu |
| 730000 |
| China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 511285 | China |
| North China University of Technology Affiliated Hospital | Tangshan | Hebei | 063000 | China |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | 473000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| Nanjing Gulou Hospital | Nanjing | Jiangsu | 210000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330038 | China |
| Xi'an Central Hospital | Xi’an | Shanxi | 710000 | China |
| Hospital of Hematology, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |