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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2024-06-25

Brief Summary

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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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Detailed Description

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Conditions

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Prevention of Venous Thromboembolism After Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR-2004 injection compared with Enoxaparin sodium injection

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment group A: SHR-2004 injection

Group Type EXPERIMENTAL

SHR-2004 injection

Intervention Type DRUG

low dose subcutaneous injection once

Treatment group B: SHR-2004 injection

Group Type EXPERIMENTAL

SHR-2004 injection

Intervention Type DRUG

medium dose subcutaneous injection once

Treatment group C: SHR-2004 injection

Group Type EXPERIMENTAL

SHR-2004 injection

Intervention Type DRUG

high dose subcutaneous injection once

Treatment group D: Enoxaparin sodium injection

Group Type ACTIVE_COMPARATOR

Enoxaparin sodium injection

Intervention Type DRUG

40 mg administered as subcutaneous injection once daily

Interventions

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SHR-2004 injection

low dose subcutaneous injection once

Intervention Type DRUG

SHR-2004 injection

medium dose subcutaneous injection once

Intervention Type DRUG

SHR-2004 injection

high dose subcutaneous injection once

Intervention Type DRUG

Enoxaparin sodium injection

40 mg administered as subcutaneous injection once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No