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

Phase 2

Completed

• Conditions: Prevention of Venous Thromboembolism After Knee Arthroplasty
• Interventions: Drug: Enoxaparin sodium injection; Drug: SHR-2004 injection

• Registration Number: NCT05752461
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-02
• Study Start: 2023-04-12
• Primary Completion: 2024-04-12
• Study Completion: 2024-06-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

1. Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent
2. Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
3. Male or female(≥ 40 years old and < 80 years old)

Exclusion Criteria

1. Unable to receive CT angiography of both lower limbs;

2. Malignant tumor within one year of the screening ;

3. History of venous thromboembolism;

4. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;

5. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding

6. 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

7. History of drug abuse;

8. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group D: Enoxaparin sodium injection	Enoxaparin sodium injection	-
Treatment group A: SHR-2004 injection	SHR-2004 injection	-
Treatment group B: SHR-2004 injection	SHR-2004 injection	-
Treatment group C: SHR-2004 injection	SHR-2004 injection	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China