NCT06825416

A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

A Multicenter, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,166 (actual)
• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 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 Arterial and Venous Thrombosis

Interventions

Type	Name	Description
DRUG	SHR-2004 injection	SHR-2004 injection in low dose.
DRUG	SHR-2004 injection	SHR-2004 injection in high dose.
DRUG	Enoxaparin sodium injection	Enoxaparin sodium injection.
DRUG	Enoxaparin sodium injection placebo	Enoxaparin sodium injection placebo.
DRUG	SHR-2004 placebo	SHR-2004 placebo in low dose.
DRUG	SHR-2004 placebo	SHR-2004 placebo in high dose.

Timeline

• Start date: 2025-03-16
• Primary completion: 2026-02-15
• Completion: 2026-04-10
• First posted: 2025-02-13
• Last updated: 2026-04-13

Locations

2 sites across 1 country: China