SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

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

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: Recruiting
• Conditions: Prevention of Venous Thromboembolism After Knee Arthroplasty
• Intervention / Treatment: Drug: SHR-2004 injection; Drug: SHR-2004 injection; Drug: SHR-2004 injection; Drug: Enoxaparin sodium injection

• Study Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhuang Nie; Phone Number: +0518-82342973; Email: zhuang.nie@hengrui.com
• Study Contact Backup: Name: Xiaojian Gao; Phone Number: +8618510128450,; Email: xiaojian.gao@hengrui.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital Central South University
      • Principal Investigator: Guanghua Lei
      • Principal Investigator: Wenfeng Xiao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent
2. Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
3. Male or female(≥ 40 years old and < 80 years old)

Exclusion Criteria:

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

6. 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

7. History of drug abuse;
8. Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: SHR-2004 injection	Drug: SHR-2004 injection; low dose subcutaneous injection once; Drug: SHR-2004 injection; medium dose subcutaneous injection once; Drug: SHR-2004 injection; high dose subcutaneous injection once
Experimental: Treatment group B: SHR-2004 injection	Drug: SHR-2004 injection; low dose subcutaneous injection once; Drug: SHR-2004 injection; medium dose subcutaneous injection once; Drug: SHR-2004 injection; high dose subcutaneous injection once
Experimental: Treatment group C: SHR-2004 injection	Drug: SHR-2004 injection; low dose subcutaneous injection once; Drug: SHR-2004 injection; medium dose subcutaneous injection once; Drug: SHR-2004 injection; high dose subcutaneous injection once
Active Comparator: Treatment group D: Enoxaparin sodium injection	Drug: Enoxaparin sodium injection; 40 mg administered as subcutaneous injection once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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）	Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）	Day 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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）	Day 85
Incidence of composite endpoint of any bleeding（Secondary safety endpoint）	Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）	Day 85

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Anticipated): June 15, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: SHR-2004-201

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