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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2026-04-15

Brief Summary

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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).

Detailed Description

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Conditions

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Knee Arthroplasty, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

KN060 Low

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

KN060 Middle

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

KN060 Hight

Intervention Type DRUG

Single dose of KN060 administered as intravenous infusion

Interventions

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Enoxaparin

40 mg enoxaparin administered as subcutaneous injection once daily

Intervention Type DRUG

KN060 Low

Single dose of KN060 administered as intravenous infusion

Intervention Type DRUG

KN060 Middle

Single dose of KN060 administered as intravenous infusion

Intervention Type DRUG

KN060 Hight

Single dose of KN060 administered as intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Alphamab Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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China

Other Identifiers

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KN060-A-201

Identifier Type: -

Identifier Source: org_study_id

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