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Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Recruiting
18-80 years
All
Phase 3

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Overview

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

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 details
    Prevention of Arterial and Venous Thrombosis

NCT06825416

Beijing Suncadia Pharmaceuticals Co., Ltd

15 October 2025

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