Status:
ACTIVE_NOT_RECRUITING
Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Lead Sponsor:
Suzhou Alphamab Co., Ltd.
Conditions:
Knee Arthroplasty, Total
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2026
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT06180889
Start Date
December 20 2023
End Date
April 15 2026
Last Update
September 17 2025
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China