SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty

Official Title
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A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral Total Knee Arthroplasty

Conditions
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Prevention of Venous Thromboembolism After Knee Arthroplasty

Intervention / Treatment
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* Drug: SHR-2004 injection
* Drug: SHR-2004 injection
* Drug: SHR-2004 injection
* Drug: Enoxaparin sodium injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent Scheduled to undergo elective unilateral total knee arthroplayts (TKA) Male or female(≥ 40 years old and < 80 years old) Exclusion Criteria: Unable to receive CT angiography of both lower limbs; Malignant tumor within one year of the screening ; History of venous thromboembolism; Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening; Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding Any of the laboratory test indicators meets the following criteria: ①estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 ; ②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal value (ULN); ③total bilirubin was > 2 times, etc History of drug abuse; Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR-2004 injection compared with Enoxaparin sodium injection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: SHR-2004 injection<br> | Drug: SHR-2004 injection<br>* low dose subcutaneous injection once<br>|
| Experimental: Treatment group B: SHR-2004 injection<br> | Drug: SHR-2004 injection<br>* medium dose subcutaneous injection once<br>|
| Experimental: Treatment group C: SHR-2004 injection<br> | Drug: SHR-2004 injection<br>* high dose subcutaneous injection once<br>|
| Active Comparator: Treatment group D: Enoxaparin sodium injection<br> | Drug: Enoxaparin sodium injection<br>* 40 mg administered as subcutaneous injection once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome） |  | Day 12 | 
| Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome） |  | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint） |  | Day 85 | 
| Incidence of composite endpoint of any bleeding（Secondary safety endpoint） |  | Day 12 | 
| Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint） |  | Day 85 |