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A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
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
SHR-2004 injection
SHR-2004 injection in low dose.
SHR-2004 injection
SHR-2004 injection in high dose.
Enoxaparin sodium injection
Enoxaparin sodium injection.
Enoxaparin sodium injection placebo
Enoxaparin sodium injection placebo.
SHR-2004 placebo
SHR-2004 placebo in low dose.
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