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

September 16, 2025 updated by: Suzhou Alphamab Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Up to 14 days
DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator
Up to 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Time Frame: Up to 14 days
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
Time Frame: Up to 35\100 days
All suspected events were reviewed and classified by the investigator
Up to 35\100 days
Incidence of symptomatic DVT, non-fatal PE
Time Frame: Up to 14 \35\100 days
All suspected events were reviewed and classified by the investigator
Up to 14 \35\100 days
Incidence of fatal PE
Time Frame: Up to 14 \35\100 days
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
Time Frame: Up to 14 \35\100 days
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
Time Frame: Up to 35\100 days
All suspected events were reviewed and classified by the investigator
Up to 35\100 days
Incidence of bleeding
Time Frame: Up to 14 \35\100 days
All suspected events were reviewed and classified by the investigator
Up to 14 \35\100 days
Incidence of major bleeding
Time Frame: Up to 14 \35\100 days
All suspected events were reviewed and classified by the investigator
Up to 14 \35\100 days
Incidence of clinically relevant non-major bleeding
Time Frame: Up to 14 \35\100 days
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
Time Frame: Up to 14 \35\100 days
All suspected events were reviewed and classified by the investigator
Up to 14 \35\100 days
Plasma Concentration of KN060
Time Frame: Up to 100 days
Up to 100 days
Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline;
Time Frame: Up to 100 days
Free FⅪ: Free Factor XI; Factor XI is a clotting factor.
Up to 100 days
Pharmacodynamics index: Changes of FⅪ activity from baseline;
Time Frame: Up to 100 days
FⅪ: Factor XI; Factor XI is a clotting factor.
Up to 100 days
Pharmacodynamics index: Changes of APTT from baseline;
Time Frame: Up to 100 days
APTT: activated partial thromboplastin time;
Up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Alphamab Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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