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

Beijing Suncadia Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Prevention of Arterial and Venous Thrombosis

Treatments: Drug: SHR-2004 placebo; Drug: SHR-2004 injection; Drug: Enoxaparin sodium injection; Drug: Enoxaparin sodium injection placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06825416

SHR-2004-301

Details and patient eligibility

About

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.

Enrollment: 1,167 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,167 participants in 3 patient groups

Group A

Experimental group

Treatment:

Drug: Enoxaparin sodium injection placebo

Drug: SHR-2004 injection

Drug: SHR-2004 placebo

Drug: SHR-2004 injection

Drug: SHR-2004 placebo

Group B

Experimental group

Treatment:

Drug: Enoxaparin sodium injection placebo

Drug: SHR-2004 injection

Drug: SHR-2004 placebo

Drug: SHR-2004 injection

Drug: SHR-2004 placebo

Group C

Active Comparator group

Treatment:

Drug: SHR-2004 placebo

Drug: Enoxaparin sodium injection

Drug: SHR-2004 placebo