NCT05752461

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prevention of Venous Thromboembolism After Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	SHR-2004 injection	low dose subcutaneous injection once
DRUG	SHR-2004 injection	medium dose subcutaneous injection once
DRUG	SHR-2004 injection	high dose subcutaneous injection once
DRUG	Enoxaparin sodium injection	40 mg administered as subcutaneous injection once daily

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-04-12
• Completion: 2024-06-25
• First posted: 2023-03-02
• Last updated: 2025-01-20

Locations

1 site across 1 country: China