Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

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.

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Drug: Enoxaparin; Drug: KN060 Low; Drug: KN060 Middle; Drug: KN060 Hight

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enoxaparin; Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery.	Drug: Enoxaparin; 40 mg enoxaparin administered as subcutaneous injection once daily
Experimental: KN060 Low (post-surgery); Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery.	Drug: KN060 Low; Single dose of KN060 administered as intravenous infusion
Experimental: KN060 Middle (post-surgery); Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery.	Drug: KN060 Middle; Single dose of KN060 administered as intravenous infusion
Experimental: KN060 Hight (post-surgery); Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery.	Drug: KN060 Hight; Single dose of KN060 administered as intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Suzhou Alphamab Co., Ltd.
• Investigators: Principal Investigator: 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: 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: 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: Yayi Xia, Doctor, Lanzhou University Second Hospital; Principal Investigator: Jun Xiao, Doctor, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Enoxaparin
• Other Study ID Numbers: KN060-A-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No