Clinical trial NCT06180889: Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Official title: An Open, Randomized, Active-comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of Different Doses of KN060 for the Prevention of Venous Thromboembolism in Patients Undergoing Unilateral Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Knee Arthroplasty, Total
Lead sponsor: Suzhou Alphamab Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Male or female, aged between 18 and 75 years old (including the cut-off value);
2. undergoing unilateral Total Knee Arthroplasty (TKA);
3. Voluntarily participate in the study and sign a written informed consent;

Exclusion Criteria:

1. There is a high risk of bleeding or abnormal bleeding related indicators:
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.

Primary outcomes:
measure: 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
timeFrame: Up to 14 days
Secondary outcomes:
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding
timeFrame: Up to 14 days
measure: 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
timeFrame: Up to 35\100 days
measure: Incidence of symptomatic DVT, non-fatal PE
timeFrame: Up to 14 \35\100 days
measure: Incidence of fatal PE
timeFrame: Up to 14 \35\100 days
measure: Incidence of unexplained death for which PE cannot be excluded
timeFrame: Up to 14 \35\100 days
measure: Incidence of composite endpoint of major and clinically relevant non-major bleeding
timeFrame: Up to 35\100 days
measure: Incidence of bleeding
timeFrame: Up to 14 \35\100 days
measure: Incidence of major bleeding
timeFrame: Up to 14 \35\100 days
measure: Incidence of clinically relevant non-major bleeding
timeFrame: Up to 14 \35\100 days
measure: Incidence of treatment emergent adverse event/adverse drug reaction
timeFrame: Up to 14 \35\100 days
measure: Plasma Concentration of KN060
timeFrame: Up to 100 days
measure: Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline;
timeFrame: Up to 100 days
measure: Pharmacodynamics index: Changes of FⅪ activity from baseline;
timeFrame: Up to 100 days
measure: Pharmacodynamics index: Changes of APTT from baseline;
timeFrame: Up to 100 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Xianlong Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai East Hospital of Tongji University
name: Feng Yin, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Zhenjun Yao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei Medical University Third Hospital
name: Shijun Gao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongda Hospital
name: Jun Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital Of Bengbu Medicai College
name: Xinshe Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hefei First People's Hospital
name: Rende Ning, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Lidong Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Fujian Medical University
name: Wenming Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Lanzhou University Second Hospital
name: Yayi Xia, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Hospital of Changsha
name: Song Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital Of Xingxiang Medical University
name: Tan Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The People's Hospital of Gaozhou
name: Chunming Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Jun Xiao, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Pengde Kang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Min Dai, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Wei Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital Of Guizhou Medical University
name: Jiangwei Li, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Jishuitan Hosptial Guizhou Hospital
name: Bensen Tang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Guizhou Provincial Peoples Hospital
name: Li Sun, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tsinghua Changgeng Hospital
name: Xu Cai, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Yantai Yuhuangding Hospital
name: Xin Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Huiwu Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: