Active — Not RecruitingPhase 2

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

China241 participantsStarted 2023-12-20

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

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

Timeframe: Up to 14 days

Trial details

NCT IDNCT06180889

SponsorSuzhou Alphamab Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-15

View on ClinicalTrials.gov More Knee Arthroplasty, Total trials