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

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).

Conditions

• Knee Arthroplasty, Total

Interventions

DRUG

Enoxaparin

40 mg enoxaparin administered as subcutaneous injection once daily

DRUG

KN060 Low

Single dose of KN060 administered as intravenous infusion

DRUG

KN060 Middle

Single dose of KN060 administered as intravenous infusion

DRUG

KN060 Hight

Single dose of KN060 administered as intravenous infusion

Sponsors & Collaborators

• Suzhou Alphamab Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Xianlong Zhang, Doctor · Shanghai 6th People's Hospital

• Feng Yin, Doctor · Shanghai East Hospital of Tongji University

• Zhenjun Yao, Doctor · Fudan University

• Shijun Gao, Doctor · Hebei Medical University Third Hospital

• Jun Lu, Doctor · Zhongda Hospital

• Xinshe Zhou, Doctor · The First Affiliated Hospital Of Bengbu Medicai College

• Rende Ning, Doctor · Hefei First People's Hospital

• Lidong Wu, Doctor · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Wenming Zhang, Doctor · First Affiliated Hospital of Fujian Medical University

• Yayi Xia, Doctor · Lanzhou University Second Hospital

• Song Chen, Doctor · The Third Hospital of Changsha

• Tan Lu, Doctor · The First Affiliated Hospital Of Xingxiang Medical University

• Chunming Huang, Doctor · The People's Hospital of Gaozhou

• Jun Xiao, Doctor · Tongji Hospital

• Pengde Kang, Doctor · West China Hospital

• Min Dai, Doctor · The First Affiliated Hospital of Nanchang University

• Wei Huang, Doctor · First Affiliated Hospital of Chongqing Medical University

• Jiangwei Li, Doctor · The Affiliated Hospital Of Guizhou Medical University

• Bensen Tang, Doctor · Beijing Jishuitan Hosptial Guizhou Hospital

• Li Sun, Doctor · Guizhou Provincial Peoples Hospital

• Xu Cai, Doctor · Beijing Tsinghua Changgeng Hospital

• Xin Wang, Doctor · Yantai Yuhuangding Hospital

• Huiwu Li, Doctor · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-20

Primary Completion

2025-12-15

Completion

2026-04-15

Countries

• China

Study Locations