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Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2173 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 Injection | Drug | SHR-2173 injection treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI) | About in the ninth month | |
| The severity of adverse events (AE) and serious adverse events (SAE) and adverse events of special concern (AESI) | About in the ninth month | |
| Changes in abnormal indicators in laboratory inspection | About in the ninth month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving remission response at week 13 of the treatment period | About in the fourth month | |
| Percentage of subjects achieving remission response at week 25 of the treatment period | About in the sixth month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junye Xiong | Contact | 0518-82342973 | junye.xiong@hengrui.com | |
| Zuxiang Jin | Contact | zuxiang.jin@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| Percentage of participants achieving remission response at any time during the treatment period | About in the ninth month |
| Proportion of participants achieving confirmed remission after SHR-2173 injection treatment | About in the ninth month |
| Time from first SHR-2173 injection treatment to confirmed remission | About in the ninth month |
| Duration from first confirmed remission to date of remission loss | About in the ninth month |
| Number and severity of bleeding events | About in the ninth month |
| Percentage of participants requiring rescue therapy | About in the ninth month |
| Serum concentration of SHR-2173 | About in the ninth month |
| Anti-SHR-2173 antibodies | About in the ninth month |
| Serum immunoglobulin levels | About in the ninth month |
| Count and percentage of B cells and subsets in peripheral blood | About in the ninth month |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |