NCT06825416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,166

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

February 9, 2025

Last Update Submit

April 9, 2026

Conditions

Prevention of Arterial and Venous Thrombosis

Outcome Measures

Primary Outcomes (2)

  • Incidence of asymptomatic deep vein thrombosis (DVT)

    Day 12.

  • Incidence of non-fatal pulmonary embolism (PE)

    Day 12.

Secondary Outcomes (2)

  • Adverse events (AEs)

    Day 65.

  • Bleeding events

    Day 12.

Study Arms (3)

Group A

EXPERIMENTAL
Drug: SHR-2004 injectionDrug: Enoxaparin sodium injection placeboDrug: SHR-2004 placebo

Group B

EXPERIMENTAL
Drug: SHR-2004 injectionDrug: Enoxaparin sodium injection placeboDrug: SHR-2004 placebo

Group C

ACTIVE COMPARATOR
Drug: Enoxaparin sodium injectionDrug: SHR-2004 placebo

Interventions

SHR-2004 injectionDRUG

SHR-2004 injection in low dose.

Group A
Enoxaparin sodium injectionDRUG

Enoxaparin sodium injection.

Group C
Enoxaparin sodium injection placeboDRUG

Enoxaparin sodium injection placebo.

Group AGroup B
SHR-2004 placeboDRUG

SHR-2004 placebo in low dose.

Group BGroup C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fourth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

enoxaparin sodium

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2025

First Posted

February 13, 2025

Study Start

March 16, 2025

Primary Completion

February 15, 2026

Study Completion

April 10, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CN(2)