Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
NCT ID: NCT06180889
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
241 participants
INTERVENTIONAL
2023-12-20
2026-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Enoxaparin
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery.
Enoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
KN060 Low (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery.
KN060 Low
Single dose of KN060 administered as intravenous infusion
KN060 Middle (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery.
KN060 Middle
Single dose of KN060 administered as intravenous infusion
KN060 Hight (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery.
KN060 Hight
Single dose of KN060 administered as intravenous infusion
Interventions
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Enoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
KN060 Low
Single dose of KN060 administered as intravenous infusion
KN060 Middle
Single dose of KN060 administered as intravenous infusion
KN060 Hight
Single dose of KN060 administered as intravenous infusion
Eligibility Criteria
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Inclusion Criteria
2. undergoing unilateral Total Knee Arthroplasty (TKA);
3. Voluntarily participate in the study and sign a written informed consent;
Exclusion Criteria
2. Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.
3. Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.
4. Presence of malignant tumors or history of malignant tumors.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Alphamab Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xianlong Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th People's Hospital
Feng Yin, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital of Tongji University
Zhenjun Yao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Shijun Gao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Third Hospital
Jun Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Xinshe Zhou, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital Of Bengbu Medicai College
Rende Ning, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hefei First People's Hospital
Lidong Wu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Wenming Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Fujian Medical University
Yayi Xia, Doctor
Role: PRINCIPAL_INVESTIGATOR
Lanzhou University Second Hospital
Song Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Third Hospital of Changsha
Tan Lu, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital Of Xingxiang Medical University
Chunming Huang, Doctor
Role: PRINCIPAL_INVESTIGATOR
The People's Hospital of Gaozhou
Jun Xiao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Pengde Kang, Doctor
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Min Dai, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Nanchang University
Wei Huang, Doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Jiangwei Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital Of Guizhou Medical University
Bensen Tang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Jishuitan Hosptial Guizhou Hospital
Li Sun, Doctor
Role: PRINCIPAL_INVESTIGATOR
Guizhou Provincial Peoples Hospital
Xu Cai, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Tsinghua Changgeng Hospital
Xin Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Yantai Yuhuangding Hospital
Huiwu Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Locations
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Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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KN060-A-201
Identifier Type: -
Identifier Source: org_study_id
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