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Completed

NCT Number: NCT06825416

A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing 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.

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Key information

Conditions

Prevention of Arterial and Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fourth Medical Center of Chinese People's Liberation Army General Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

SHR-2004 injection

Drug

SHR-2004 injection in low dose.

Enoxaparin sodium injection

Drug

Enoxaparin sodium injection.

Enoxaparin sodium injection placebo

Drug

Enoxaparin sodium injection placebo.

SHR-2004 placebo

Drug

SHR-2004 placebo in low dose.

Primary outcomes

  1. Incidence of asymptomatic deep vein thrombosis (DVT)

    Time frame: Day 12.

  2. Incidence of non-fatal pulmonary embolism (PE)

    Time frame: Day 12.

Secondary outcomes

  1. Adverse events (AEs)

    Time frame: Day 65.

  2. Bleeding events

    Time frame: Day 12.

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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