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

Last updated: December 28, 2023
Sponsor: Suzhou Alphamab Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Venous Thrombosis

Thromboembolism

Venous Thromboembolism

Treatment

KN060 Low

KN060 Middle

Enoxaparin

Clinical Study ID

NCT06180889
KN060-A-201
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 auxiliarytests indicating thrombosis; Or have a history of venous embolic disease.
  3. Acute myocardial infarction or ischemic stroke occurred within 6 months beforescreening.
  4. Presence of malignant tumors or history of malignant tumors.

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: KN060 Low
Phase: 2
Study Start date:
December 20, 2023
Estimated Completion Date:
April 15, 2026

Connect with a study center

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

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