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This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin | Active Comparator | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery. |
|
| KN060 Low (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery. |
|
| KN060 Middle (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery. |
|
| KN060 Hight (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | 40 mg enoxaparin administered as subcutaneous injection once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded | DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite endpoint of major and clinically relevant non-major bleeding | All suspected events were reviewed and classified by the investigator | Up to 14 days |
| Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xianlong Zhang, Doctor | Shanghai 6th People's Hospital | Principal Investigator |
| Feng Yin, Doctor | Shanghai East Hospital of Tongji University | Principal Investigator |
| Zhenjun Yao, Doctor | Fudan University | Principal Investigator |
| Shijun Gao, Doctor | Hebei Medical University Third Hospital | Principal Investigator |
| Jun Lu, Doctor | Zhongda Hospital | Principal Investigator |
| Xinshe Zhou, Doctor | The First Affiliated Hospital Of Bengbu Medicai College | Principal Investigator |
| Rende Ning, Doctor | Hefei First People's Hospital | Principal Investigator |
| Lidong Wu, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Wenming Zhang, Doctor | First Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| KN060 Low |
| Drug |
Single dose of KN060 administered as intravenous infusion |
|
| KN060 Middle | Drug | Single dose of KN060 administered as intravenous infusion |
|
| KN060 Hight | Drug | Single dose of KN060 administered as intravenous infusion |
|
All suspected events were reviewed and classified by the investigator |
| Up to 35\100 days |
| Incidence of symptomatic DVT, non-fatal PE | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Incidence of fatal PE | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Incidence of unexplained death for which PE cannot be excluded | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Incidence of composite endpoint of major and clinically relevant non-major bleeding | All suspected events were reviewed and classified by the investigator | Up to 35\100 days |
| Incidence of bleeding | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Incidence of major bleeding | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Incidence of clinically relevant non-major bleeding | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Incidence of treatment emergent adverse event/adverse drug reaction | All suspected events were reviewed and classified by the investigator | Up to 14 \35\100 days |
| Plasma Concentration of KN060 | Up to 100 days |
| Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline; | Free FⅪ: Free Factor XI; Factor XI is a clotting factor. | Up to 100 days |
| Pharmacodynamics index: Changes of FⅪ activity from baseline; | FⅪ: Factor XI; Factor XI is a clotting factor. | Up to 100 days |
| Pharmacodynamics index: Changes of APTT from baseline; | APTT: activated partial thromboplastin time; | Up to 100 days |
| Yayi Xia, Doctor | Lanzhou University Second Hospital | Principal Investigator |
| Song Chen, Doctor | The Third Hospital of Changsha | Principal Investigator |
| Tan Lu, Doctor | The First Affiliated Hospital Of Xingxiang Medical University | Principal Investigator |
| Chunming Huang, Doctor | The People's Hospital of Gaozhou | Principal Investigator |
| Jun Xiao, Doctor | Tongji Hospital | Principal Investigator |
| Pengde Kang, Doctor | West China Hospital | Principal Investigator |
| Min Dai, Doctor | The First Affiliated Hospital of Nanchang University | Principal Investigator |
| Wei Huang, Doctor | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Jiangwei Li, Doctor | The Affiliated Hospital Of Guizhou Medical University | Principal Investigator |
| Bensen Tang, Doctor | Beijing Jishuitan Hosptial Guizhou Hospital | Principal Investigator |
| Li Sun, Doctor | Guizhou Provincial Peoples Hospital | Principal Investigator |
| Xu Cai, Doctor | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Xin Wang, Doctor | Yantai Yuhuangding Hospital | Principal Investigator |
| Huiwu Li, Doctor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| D002241 |
| Carbohydrates |