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

NCT06180889 | Active Not Recruiting Phase 2

• 1 other identifier: KN060-A-201
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Incidence of composite endpoint of major and clinically relevant non-major bleeding

  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

  Up to 35\100 days

• Incidence of symptomatic DVT, non-fatal PE

  Up to 14 \35\100 days

• Incidence of fatal PE

  Up to 14 \35\100 days

• Incidence of unexplained death for which PE cannot be excluded

  Up to 14 \35\100 days

Study Arms (4)

Enoxaparin

ACTIVE COMPARATOR

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery.

Drug: Enoxaparin

KN060 Low (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery.

Drug: KN060 Low

KN060 Middle (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery.

Drug: KN060 Middle

KN060 Hight (post-surgery)

EXPERIMENTAL

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery.

Drug: KN060 Hight

Interventions

Enoxaparin DRUG

40 mg enoxaparin administered as subcutaneous injection once daily

Enoxaparin

KN060 Low DRUG

Single dose of KN060 administered as intravenous infusion

KN060 Low (post-surgery)

KN060 Middle DRUG

Single dose of KN060 administered as intravenous infusion

KN060 Middle (post-surgery)

KN060 Hight DRUG

Single dose of KN060 administered as intravenous infusion

KN060 Hight (post-surgery)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• There is a high risk of bleeding or abnormal bleeding related indicators:
• Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.
• Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.
• Presence of malignant tumors or history of malignant tumors.

Sponsors & Collaborators

• Suzhou Alphamab Co., Ltd.: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• 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

• Yayi Xia, Doctor

  Lanzhou University Second Hospital

  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

• Jun Xiao, Doctor

  Tongji Hospital

  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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 26, 2023
• Study Start: December 20, 2023
• Primary Completion: December 15, 2025
• Study Completion: April 15, 2026
• Last Updated: September 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)