Prevention of Venous Thromboembolism After Knee ArthroplastyPhase 2NCT05752461
SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
A Phase 2 study testing SHR-2004 injection and Enoxaparin sodium injection in people with Prevention of Venous Thromboembolism After Knee Arthroplasty, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site 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 40 to 80 years
- Conditions the study is for
- Prevention of Venous Thromboembolism After Knee Arthroplasty
- What is being tested?
- SHR-2004 injection and Enoxaparin sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2023to 25 Jun 2024
- Phase
- Phase 2
- 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 40 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 the study, and sign the informed consent
- Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- Male or female(≥ 40 years old and < 80 years old)
Who cannot join
- Unable to receive CT angiography of both lower limbs;
- Malignant tumor within one year of the screening ;
- History of venous thromboembolism;
- 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
- Any of the laboratory test indicators meets the following criteria:
Show all 11Show fewer
- ①estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 ;
- ②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal value (ULN);
- ③total bilirubin was > 2 times, etc
- History of drug abuse;
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2004 injectionDrug
low dose subcutaneous injection once
SHR-2004 injectionDrug
medium dose subcutaneous injection once
SHR-2004 injectionDrug
high dose subcutaneous injection once
Enoxaparin sodium injectionDrug
40 mg administered as subcutaneous injection once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR-2004 injection | Experimental | Not described Receives: Drug: SHR-2004 injection |
| Treatment group B: SHR-2004 injection | Experimental | Not described Receives: Drug: SHR-2004 injection |
| Treatment group C: SHR-2004 injection | Experimental | Not described Receives: Drug: SHR-2004 injection |
| Treatment group D: Enoxaparin sodium injection | Active comparator | Not described Receives: Drug: Enoxaparin sodium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome）
Measured: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
Measured: Day 12
Secondary outcomes (3)
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint）
Measured: Day 85
Incidence of composite endpoint of any bleeding（Secondary safety endpoint）
Measured: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start12 Apr 2023
- Primary completion12 Apr 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Venous Thromboembolism After Knee ArthroplastyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR-2004 injection compared with Enoxaparin sodium injection
- Masking
- None (open label)
- Enrolment
- 353 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
- NCT05752461
- Sponsor's protocol ID
- SHR-2004-201
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2023
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05752461
- Acronym / sponsor ID
- SHR-2004-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 2 Mar 2023 (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
- None (open label)
- Number of arms
- 4
- Model description
- SHR-2004 injection compared with Enoxaparin sodium injection
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR-2004 injection | Experimental | Drug: SHR-2004 injection |
| Treatment group B: SHR-2004 injection | Experimental | Drug: SHR-2004 injection |
| Treatment group C: SHR-2004 injection | Experimental | Drug: SHR-2004 injection |
| Treatment group D: Enoxaparin sodium injection | Active comparator | Drug: Enoxaparin sodium injection |
Who may qualify
- Ages
- 40 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 the study, and sign the informed consent
- Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- Male or female(≥ 40 years old and < 80 years old)
Key exclusion criteria (11 listed)
- Unable to receive CT angiography of both lower limbs;
- Malignant tumor within one year of the screening ;
- History of venous thromboembolism;
- 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
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 injectionlow dose subcutaneous injection once | Drug | Treatment group A: SHR-2004 injection |
| SHR-2004 injectionmedium dose subcutaneous injection once | Drug | Treatment group B: SHR-2004 injection |
| SHR-2004 injectionhigh dose subcutaneous injection once | Drug | Treatment group C: SHR-2004 injection |
| Enoxaparin sodium injection40 mg administered as subcutaneous injection once daily | Drug | Treatment group D: Enoxaparin sodium injection |
Primary outcome
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome）
Time frame: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
Time frame: Day 12
3 secondary outcomes
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint）
Time frame: Day 85
Incidence of composite endpoint of any bleeding（Secondary safety endpoint）
Time frame: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）
Time frame: Day 85
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 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Prevention of Venous Thromboembolism After Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 2
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
Circulatory Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-2004 injection and Enoxaparin sodium injection in people with Prevention of Venous Thromboembolism After Knee Arthroplasty, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site 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 11 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 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome） (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 20 Jan 2025.