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

Phase 2

Recruiting

• Conditions: Knee Arthroplasty, Total
• Interventions: Drug: KN060 Low; Drug: KN060 Middle; Drug: KN060 Hight; Drug: Enoxaparin

• Registration Number: NCT06180889
• Lead Sponsor: Suzhou Alphamab Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-12
• Study Start: 2023-12-20
• Study First Posted: 2023-12-26
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29
• Primary Completion: 2025-12-15
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KN060 Low (post-surgery)	KN060 Low	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery.
KN060 Middle (post-surgery)	KN060 Middle	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery.
KN060 Hight (post-surgery)	KN060 Hight	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery.
Enoxaparin	Enoxaparin	Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery.

Primary Outcome Measures

Name	Time	Method
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	Up to 14 days	DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China