A Clinical Study of SHR-2004 Injection in Preventing Veno... | NCT06825416

Studies
A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

NCT06825416

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Status

Completed

Last Update Posted

Apr 13, 2026Actual

Enrollment

1,166Actual

Phase

Phase 3

Conditions

Prevention of Arterial and Venous Thrombosis

Interventions

SHR-2004 injection
SHR-2004 injection
Enoxaparin sodium injection
Enoxaparin sodium injection placebo
SHR-2004 placebo
SHR-2004 placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2025Actual

Primary Completion Date

Feb 15, 2026Actual

Completion Date

Apr 10, 2026Actual

First Submitted Date

Feb 9, 2025

First Submission Date that Met QC Criteria

Feb 9, 2025

First Posted Date

Feb 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group A	Experimental	Drug: SHR-2004 injection Drug: Enoxaparin sodium injection placebo Drug: SHR-2004 placebo
Group B	Experimental	Drug: SHR-2004 injection Drug: Enoxaparin sodium injection placebo Drug: SHR-2004 placebo
Group C	Active Comparator	Drug: Enoxaparin sodium injection Drug: SHR-2004 placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-2004 injection	Drug	SHR-2004 injection in low dose.	Group A
SHR-2004 injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of asymptomatic deep vein thrombosis (DVT)		Day 12.
Incidence of non-fatal pulmonary embolism (PE)		Day 12.

Secondary Outcomes

Measure	Description	Time Frame
Adverse events (AEs)		Day 65.
Bleeding events		Day 12.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
Planned elective schedule total knee arthroplasty (TKA) patients;
Men or women who are ≥ 18 years old and < 80 years old on the day of signing the informed consent form.

Exclusion Criteria:

Unable to receive CT angiography of both lower limbs;
Malignant tumor within one year of the screening;
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;
History of drug abuse;
Pregnant or lactating women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fourth Medical Center of Chinese People's Liberation Army General Hospital		Beijing	Beijing Municipality	100048	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases