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

Knee Arthroplasty, Total Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180889
• Other study ID #: KN060-A-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Est. completion date: April 15, 2026

Study information

• Verified date: December 2023
• Source: Suzhou Alphamab Co., Ltd.
• Contact: Yanrong Dong, Master
• Phone: +86 18914005458
• Email: yanrongdong[@]alphamab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 15, 2026
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 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 auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.

3. Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.

4. Presence of malignant tumors or history of malignant tumors.

Related Conditions & MeSH terms

• Knee Arthroplasty, Total
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Enoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
• KN060 Low
Single dose of KN060 administered as intravenous infusion
• KN060 Middle
Single dose of KN060 administered as intravenous infusion
• KN060 Hight
Single dose of KN060 administered as intravenous infusion

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Alphamab Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of composite endpoint of major and clinically relevant non-major bleeding	All suspected events were reviewed and classified by the investigator	Up to 14 days
Secondary	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	All suspected events were reviewed and classified by the investigator	Up to 35\100 days
Secondary	Incidence of symptomatic DVT, non-fatal PE	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Incidence of fatal PE	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Incidence of unexplained death for which PE cannot be excluded	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Incidence of composite endpoint of major and clinically relevant non-major bleeding	All suspected events were reviewed and classified by the investigator	Up to 35\100 days
Secondary	Incidence of bleeding	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Incidence of major bleeding	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Incidence of clinically relevant non-major bleeding	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Incidence of treatment emergent adverse event/adverse drug reaction	All suspected events were reviewed and classified by the investigator	Up to 14 \35\100 days
Secondary	Plasma Concentration of KN060		Up to 100 days
Secondary	Pharmacodynamics index: Changes of plasma concentration of Free F? from baseline;	Free F?: Free Factor XI; Factor XI is a clotting factor.	Up to 100 days
Secondary	Pharmacodynamics index: Changes of F? activity from baseline;	F?: Factor XI; Factor XI is a clotting factor.	Up to 100 days
Secondary	Pharmacodynamics index: Changes of APTT from baseline;	APTT: activated partial thromboplastin time;	Up to 100 days