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Completed

NCT Number: NCT05752461

SHR-2004 for the Prevention of 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 Venous Thromboembolism After Knee Arthroplasty

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

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 the study, and sign the informed consent
  • Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
  • Male or female(≥ 40 years old and < 80 years old)

Exclusion criteria

  • Unable to receive CT angiography of both lower limbs;
  • Malignant tumor within one year of the screening ;
  • History of venous thromboembolism;
  • 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
  • Any of the laboratory test indicators meets the following criteria:

①estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 ;

②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal value (ULN);

③total bilirubin was > 2 times, etc

  • History of drug abuse;
  • Pregnant or lactating women

Treatment and study plan

SHR-2004 injection

Drug

low dose subcutaneous injection once

Enoxaparin sodium injection

Drug

40 mg administered as subcutaneous injection once daily

Primary outcomes

  1. Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome）

    Time frame: Day 12

  2. Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）

    Time frame: Day 12

Secondary outcomes

  1. Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint）

    Time frame: Day 85

  2. Incidence of composite endpoint of any bleeding（Secondary safety endpoint）

    Time frame: Day 12

  3. Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）

    Time frame: Day 85

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral Total Knee Arthroplasty

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2023
Registry last updated
Jan 20, 2025

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.