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

NCT05752461 | Completed Phase 2

• 1 other identifier: SHR-2004-201
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

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

Conditions

Prevention of Venous Thromboembolism After Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (4)

Treatment group A: SHR-2004 injection

EXPERIMENTAL

Drug: SHR-2004 injection

Treatment group B: SHR-2004 injection

EXPERIMENTAL

Drug: SHR-2004 injection

Treatment group C: SHR-2004 injection

EXPERIMENTAL

Drug: SHR-2004 injection

Treatment group D: Enoxaparin sodium injection

ACTIVE COMPARATOR

Drug: Enoxaparin sodium injection

Interventions

SHR-2004 injection DRUG

low dose subcutaneous injection once

Treatment group A: SHR-2004 injection

Enoxaparin sodium injection DRUG

40 mg administered as subcutaneous injection once daily

Treatment group D: Enoxaparin sodium injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Interventions

enoxaparin sodium

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-2004 injection compared with Enoxaparin sodium injection

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 2, 2023
• Study Start: April 12, 2023
• Primary Completion: April 12, 2024
• Study Completion: June 25, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CN (1)