Back to resultsSHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Primary Purpose
Prevention of Venous Thromboembolism After Knee Arthroplasty
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-2004 injection
SHR-2004 injection
SHR-2004 injection
Enoxaparin sodium injection
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Venous Thromboembolism After Knee Arthroplasty
Eligibility Criteria
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
Sites / Locations
- Xiangya Hospital Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Treatment group A: SHR-2004 injection
Treatment group B: SHR-2004 injection
Treatment group C: SHR-2004 injection
Treatment group D: Enoxaparin sodium injection
Arm Description
Outcomes
Primary Outcome Measures
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）
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
Secondary Outcome Measures
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）
Incidence of composite endpoint of any bleeding（Secondary safety endpoint）
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）
Full Information
NCT ID
NCT05752461
First Posted
February 22, 2023
Last Updated
April 20, 2023
Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05752461
Brief Title
SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Venous Thromboembolism After Knee Arthroplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SHR-2004 injection compared with Enoxaparin sodium injection
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A: SHR-2004 injection
Arm Type
Experimental
Arm Title
Treatment group B: SHR-2004 injection
Arm Type
Experimental
Arm Title
Treatment group C: SHR-2004 injection
Arm Type
Experimental
Arm Title
Treatment group D: Enoxaparin sodium injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-2004 injection
Intervention Description
low dose subcutaneous injection once
Intervention Type
Drug
Intervention Name(s)
SHR-2004 injection
Intervention Description
medium dose subcutaneous injection once
Intervention Type
Drug
Intervention Name(s)
SHR-2004 injection
Intervention Description
high dose subcutaneous injection once
Intervention Type
Drug
Intervention Name(s)
Enoxaparin sodium injection
Intervention Description
40 mg administered as subcutaneous injection once daily
Primary Outcome Measure Information:
Title
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
Title
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
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
Title
Incidence of composite endpoint of any bleeding（Secondary safety endpoint）
Time Frame
Day 12
Title
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）
Time Frame
Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuang Nie
Phone
+0518-82342973
Email
zhuang.nie@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojian Gao
Phone
+8618510128450,
Email
xiaojian.gao@hengrui.com
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghua Lei
First Name & Middle Initial & Last Name & Degree
Wenfeng Xiao
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
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