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

Phase 3

Recruiting

• Conditions: Prevention of Arterial and Venous Thrombosis
• Interventions: Drug: SHR-2004 injection; Drug: Enoxaparin sodium injection; Drug: Enoxaparin sodium injection placebo; Drug: SHR-2004 placebo

• Registration Number: NCT06825416
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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 available

Study Timeline

• Study First Submitted: 2025-02-09
• Study First Submitted QC: 2025-02-09
• Status Verified: 2025-03
• Study Start: 2025-03-14
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1167

Inclusion Criteria

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

Exclusion Criteria

1. Unable to receive CT angiography of both lower limbs;
2. Malignant tumor within one year of the screening;
3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
5. History of drug abuse;
6. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	SHR-2004 injection	-
Group A	Enoxaparin sodium injection placebo	-
Group A	SHR-2004 placebo	-
Group B	SHR-2004 injection	-
Group B	Enoxaparin sodium injection placebo	-
Group B	SHR-2004 placebo	-
Group C	Enoxaparin sodium injection	-
Group C	SHR-2004 placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of asymptomatic deep vein thrombosis (DVT)	Day 12.
Incidence of non-fatal pulmonary embolism (PE)	Day 12.

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Day 65.
Bleeding events	Day 12.

Trial Locations

Locations (2)

Fourth Medical Center of Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, Beijing, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China