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ACTIVE NOT RECRUITING
NCT06825416
PHASE3

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

Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1166

Start Date

2025-03-16

Completion Date

2026-12

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

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.

Locations (2)

Fourth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Xiangya Hospital, Central South University

Changsha, Hunan, China