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: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
• Planned elective schedule total knee arthroplasty (TKA) patients;
• Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form.
Locations
Other Locations
China
Fourth Medical Center of Chinese People's Liberation Army General Hospital
RECRUITING
Beijing
Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Zhuang Nie
zhuang.nie@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1167
Treatments
Experimental: Group A
Experimental: Group B
Active_comparator: Group C
Related Therapeutic Areas
Sponsors
Leads: Beijing Suncadia Pharmaceuticals Co., Ltd