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

NCT06825416
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,165
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Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
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Start date
2025-03-16
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Number of sites
2
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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.
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Short title
A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
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Official title
A Multicenter, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Arthroplasty
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-04-23
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First posted
2025-02-13
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Registry last updated
2026-08-28
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Primary completion date
2026-02-15
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Start date
2025-03-16
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Actual participants
1,165
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Participants
1,165
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
2
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Registry sponsor category
Industry
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Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06825416
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ClinicalTrials.gov ID
NCT06825416
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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  1. Incidence of asymptomatic deep vein thrombosis (DVT)

    Timeframe: Day 12.

  2. Incidence of non-fatal pulmonary embolism (PE)

    Timeframe: Day 12.

  1. Adverse events (AEs)

    Timeframe: Day 65.

  2. Bleeding events

    Timeframe: Day 12.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • Fourth Medical Center of Chinese People's Liberation Army General HospitalBeijing, China
  • Xiangya Hospital, Central South UniversityChangsha, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)