Prevention of Arterial and Venous ThrombosisPhase 3NCT06825416
A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
A Phase 3 study testing SHR-2004 injection and Enoxaparin sodium injection in people with Prevention of Arterial and Venous Thrombosis, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prevention of Arterial and Venous Thrombosis
- What is being tested?
- SHR-2004 injection and Enoxaparin sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,165 participants
- Where
- 2 sitesChina
- Study dates
- 16 Mar 2025to 23 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fourth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100048
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
About this study
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
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.
- Being tested
- SHR-2004 injection, Enoxaparin sodium injection, Enoxaparin sodium injection placebo, SHR-2004 placebo
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2004 injectionDrug
SHR-2004 injection in low dose.
SHR-2004 injectionDrug
SHR-2004 injection in high dose.
Enoxaparin sodium injectionDrug
Enoxaparin sodium injection.
Enoxaparin sodium injection placeboDrug
Enoxaparin sodium injection placebo.
SHR-2004 placeboDrug
SHR-2004 placebo in low dose.
SHR-2004 placeboDrug
SHR-2004 placebo in high dose.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: SHR-2004 injection; Drug: Enoxaparin sodium injection placebo; Drug: SHR-2004 placebo |
| Group B | Experimental | Not described Receives: Drug: SHR-2004 injection; Drug: Enoxaparin sodium injection placebo; Drug: SHR-2004 placebo |
| Group C | Active comparator | Not described Receives: Drug: Enoxaparin sodium injection; Drug: SHR-2004 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of asymptomatic deep vein thrombosis (DVT)
Measured: Day 12.
Incidence of non-fatal pulmonary embolism (PE)
Measured: Day 12.
Secondary outcomes (2)
Adverse events (AEs)
Measured: Day 65.
Bleeding events
Measured: Day 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start16 Mar 2025
- Primary completion15 Feb 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Arterial and Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825416
- Sponsor's protocol ID
- SHR-2004-301
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06825416
- Acronym / sponsor ID
- SHR-2004-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,165 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SHR-2004 injection, Drug: Enoxaparin sodium injection placebo, Drug: SHR-2004 placebo |
| Group B | Experimental | Drug: SHR-2004 injection, Drug: Enoxaparin sodium injection placebo, Drug: SHR-2004 placebo |
| Group C | Active comparator | Drug: Enoxaparin sodium injection, Drug: SHR-2004 placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2004 injectionSHR-2004 injection in low dose. | Drug | Group A |
| SHR-2004 injectionSHR-2004 injection in high dose. | Drug | Group B |
| Enoxaparin sodium injectionEnoxaparin sodium injection. | Drug | Group C |
| Enoxaparin sodium injection placeboEnoxaparin sodium injection placebo. | Drug | Group A, Group B |
| SHR-2004 placeboSHR-2004 placebo in low dose. | Drug | Group B, Group C |
| SHR-2004 placeboSHR-2004 placebo in high dose. | Drug | Group A, Group C |
Primary outcome
Incidence of asymptomatic deep vein thrombosis (DVT)
Time frame: Day 12.
Incidence of non-fatal pulmonary embolism (PE)
Time frame: Day 12.
2 secondary outcomes
Adverse events (AEs)
Time frame: Day 65.
Bleeding events
Time frame: Day 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-2004 injection and Enoxaparin sodium injection in people with Prevention of Arterial and Venous Thrombosis, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of asymptomatic deep vein thrombosis (DVT) (time frame: Day 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.