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

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.

Study Overview

• Status: Completed
• Conditions: Prevention of Arterial and Venous Thrombosis
• Intervention / Treatment: Drug: SHR-2004 injection; Drug: SHR-2004 injection; Drug: Enoxaparin sodium injection placebo; Drug: SHR-2004 placebo; Drug: SHR-2004 placebo; Drug: Enoxaparin sodium injection

• Study Type: Interventional
• Enrollment (Actual): 1166
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100048
      • Fourth Medical Center of Chinese People's Liberation Army General Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
2. Planned elective schedule total knee arthroplasty (TKA) patients;
3. Men or women who are ≥ 18 years old and < 80 years old on the day of signing the informed consent form.

Exclusion Criteria:

1. Unable to receive CT angiography of both lower limbs;
2. Malignant tumor within one year of the screening;
3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
5. History of drug abuse;
6. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: SHR-2004 injection; SHR-2004 injection in low dose.; Drug: SHR-2004 injection; SHR-2004 injection in high dose.; 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.
Experimental: Group B	Drug: SHR-2004 injection; SHR-2004 injection in low dose.; Drug: SHR-2004 injection; SHR-2004 injection in high dose.; 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.
Active Comparator: Group C	Drug: SHR-2004 placebo; SHR-2004 placebo in low dose.; Drug: SHR-2004 placebo; SHR-2004 placebo in high dose.; Drug: Enoxaparin sodium injection; Enoxaparin sodium injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of asymptomatic deep vein thrombosis (DVT)	Day 12.
Incidence of non-fatal pulmonary embolism (PE)	Day 12.

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs)	Day 65.
Bleeding events	Day 12.

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2025
• Primary Completion (Actual): February 15, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; enoxaparin sodium
• Other Study ID Numbers: SHR-2004-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No