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NCT Number: NCT06180889

Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Arthroplasty, Total

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Enoxaparin

Drug

40 mg enoxaparin administered as subcutaneous injection once daily

KN060 Low

Drug

Single dose of KN060 administered as intravenous infusion

KN060 Middle

Drug

Single dose of KN060 administered as intravenous infusion

KN060 Hight

Drug

Single dose of KN060 administered as intravenous infusion

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

    Time frame: Up to 14 days

    DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Incidence of fatal PE

    Time frame: Up to 14 \35\100 days

    All suspected events were reviewed and classified by the investigator

  5. 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

  6. 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

  7. Incidence of bleeding

    Time frame: Up to 14 \35\100 days

    All suspected events were reviewed and classified by the investigator

  8. Incidence of major bleeding

    Time frame: Up to 14 \35\100 days

    All suspected events were reviewed and classified by the investigator

  9. 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

  10. 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

  11. Plasma Concentration of KN060

    Time frame: Up to 100 days

  12. 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.

  13. Pharmacodynamics index: Changes of FⅪ activity from baseline;

    Time frame: Up to 100 days

    FⅪ: Factor XI; Factor XI is a clotting factor.

  14. Pharmacodynamics index: Changes of APTT from baseline;

    Time frame: Up to 100 days

    APTT: activated partial thromboplastin time;

Sponsors and collaborators

Lead sponsor

Suzhou Alphamab Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 26, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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