A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
NCT06825416 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1166
Last updated 2026-04-13
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
- 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.
Sponsors & Collaborators
-
Beijing Suncadia Pharmaceuticals Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-16
- Primary Completion
- 2026-02-15
- Completion
- 2026-04-10
Countries
- China
Study Locations
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