Phase III Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
NCT ID: NCT06825416
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1167 participants
INTERVENTIONAL
2025-03-14
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group A
SHR-2004 injection
SHR-2004 injection in low dose.
Enoxaparin sodium injection placebo
Enoxaparin sodium injection placebo.
SHR-2004 placebo
SHR-2004 placebo in high dose.
Group B
SHR-2004 injection
SHR-2004 injection in high dose.
Enoxaparin sodium injection placebo
Enoxaparin sodium injection placebo.
SHR-2004 placebo
SHR-2004 placebo in low dose.
Group C
Enoxaparin sodium injection
Enoxaparin sodium injection.
SHR-2004 placebo
SHR-2004 placebo in low dose.
SHR-2004 placebo
SHR-2004 placebo in high dose.
Interventions
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SHR-2004 injection
SHR-2004 injection in low dose.
SHR-2004 injection
SHR-2004 injection in high dose.
Enoxaparin sodium injection
Enoxaparin sodium injection.
Enoxaparin sodium injection placebo
Enoxaparin sodium injection placebo.
SHR-2004 placebo
SHR-2004 placebo in low dose.
SHR-2004 placebo
SHR-2004 placebo in high dose.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Suncadia Pharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Fourth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-2004-301
Identifier Type: -
Identifier Source: org_study_id
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