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

Alphamab

Status and phase: Active, not recruiting; Phase 2

Conditions: Knee Arthroplasty, Total

Treatments: Drug: KN060 Middle; Drug: KN060 Hight; Drug: Enoxaparin; Drug: KN060 Low

Study type: Interventional

Funder types: Industry

Identifiers

NCT06180889

KN060-A-201

Details and patient eligibility

About

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).

Enrollment: 241 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 4 patient groups

Enoxaparin

Active Comparator group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery.

Treatment:

Drug: Enoxaparin

KN060 Low (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery.

Treatment:

Drug: KN060 Low

KN060 Middle (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery.

Treatment:

Drug: KN060 Middle

KN060 Hight (post-surgery)

Experimental group

Description:

Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery.

Treatment:

Drug: KN060 Hight