Prevention of Venous Thrombosis After TKAPhase 2NCT05203705
Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty
A Phase 2 study testing SHR2285 tablet and Enoxaparin in people with Prevention of Venous Thrombosis After TKA, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Prevention of Venous Thrombosis After TKA
- What is being tested?
- SHR2285 tablet and Enoxaparin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2022to 14 Mar 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);
- Scheduled to undergo elective unilateral total knee arthroplasty;
- Males or females aged 40-75 years.
Who cannot join
- Weighing less than 40 kg or greater than 135 kg;
- Allergic to contrast agents rendering the patient unable to undergo venous angiography of the lower extremities; allergic to enoxaparin or any of the ingredients listed in the package insert thereof; allergic to the investigational product or any of the ingredients thereof;
- With malignant tumors that still require medical intervention; except for radically treated non-melanoma skin cancer, basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ;
- With a history of major liver disease within 1 year;
- With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Perking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of SHR2285 Tablets Following Multiple Oral Administrations in Patients Undergoing Elective Total Knee Arthroplasty: a Multicenter, Randomized, Positive-controlled Phase II Clinical Study
This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. enoxaparin for the prevention of postoperative venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty.
- Being tested
- SHR2285 tablet, Enoxaparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2285 tabletDrug
SHR2285 tablet; dose 1, for 12 days
SHR2285 tabletDrug
SHR2285 tablet; dose 2, for 12 days
SHR2285 tabletDrug
SHR2285 tablet; dose 3, for 12 days
SHR2285 tabletDrug
SHR2285 tablet; dose 4, for 12 days
EnoxaparinDrug
Enoxaparin, for 12 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | SHR2285 tablet; dose 1 Receives: Drug: SHR2285 tablet |
| Treatment group 2 | Experimental | SHR2285 tablet; dose 2 Receives: Drug: SHR2285 tablet |
| Treatment group 3 | Experimental | SHR2285 tablet; dose 3 Receives: Drug: SHR2285 tablet |
| Treatment group 4 | Experimental | SHR2285 tablet; dose 4 Receives: Drug: SHR2285 tablet |
| Treatment group 5 | Active comparator | Enoxaparin Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with confirmed composite endpoint
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) or all-cause deaths
Measured: Day 12
Number of patients with composite bleeding
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
Measured: Day 12
Secondary outcomes (2)
Number of patients with composite venous thromboembolic events (VTE)
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) ,all-cause deaths
Measured: Day 1 to Day 12
Number of patients with composite venous thromboembolic events (VTE)
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) ,all-cause deaths
Measured: Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Mar 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Why it stopped: Adjustment of the sponsor's R\&D strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Venous Thrombosis After TKAStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR2285 tablets compared with Enoxaparin
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203705
- Sponsor's protocol ID
- SHR2285-201
- Status last verified
- Oct 2025
- First submitted
- 20 Jan 2022
- Last updated
- 17 Nov 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SHR2285 Tablets Following Multiple Oral Administrations in Patients Undergoing Elective Total Knee Arthroplasty: a Multicenter, Randomized, Positive-controlled Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05203705
- Acronym / sponsor ID
- SHR2285-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of the sponsor's R\&D strategy
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 24 Jan 2022 (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.
This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. enoxaparin for the prevention of postoperative venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- SHR2285 tablets compared with Enoxaparin
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: SHR2285 tabletSHR2285 tablet; dose 1 |
| Treatment group 2 | Experimental | Drug: SHR2285 tabletSHR2285 tablet; dose 2 |
| Treatment group 3 | Experimental | Drug: SHR2285 tabletSHR2285 tablet; dose 3 |
| Treatment group 4 | Experimental | Drug: SHR2285 tabletSHR2285 tablet; dose 4 |
| Treatment group 5 | Active comparator | Drug: EnoxaparinEnoxaparin |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);
- Scheduled to undergo elective unilateral total knee arthroplasty;
- Males or females aged 40-75 years.
Key exclusion criteria (5 listed)
- Weighing less than 40 kg or greater than 135 kg;
- Allergic to contrast agents rendering the patient unable to undergo venous angiography of the lower extremities; allergic to enoxaparin or any of the ingredients listed in the package insert thereof; allergic to the investigational product or any of the ingredients thereof;
- With malignant tumors that still require medical intervention; except for radically treated non-melanoma skin cancer, basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ;
- With a history of major liver disease within 1 year;
- With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.
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 |
|---|---|---|
| SHR2285 tabletSHR2285 tablet; dose 1, for 12 days | Drug | Treatment group 1 |
| SHR2285 tabletSHR2285 tablet; dose 2, for 12 days | Drug | Treatment group 2 |
| SHR2285 tabletSHR2285 tablet; dose 3, for 12 days | Drug | Treatment group 3 |
| SHR2285 tabletSHR2285 tablet; dose 4, for 12 days | Drug | Treatment group 4 |
| EnoxaparinEnoxaparin, for 12 days | Drug | Treatment group 5 |
Primary outcome
Number of patients with confirmed composite endpoint
Time frame: Day 12
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) or all-cause deaths
Number of patients with composite bleeding
Time frame: Day 12
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
2 secondary outcomes
Number of patients with composite venous thromboembolic events (VTE)
Time frame: Day 1 to Day 12
Number of patients with composite venous thromboembolic events (VTE)
Time frame: Day 1 to Day 42
Results and safety
The study was stopped early (reason given: Adjustment of the sponsor's R\&D strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Prevention of Venous Thrombosis After TKA
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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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.
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 SHR2285 tablet and Enoxaparin in people with Prevention of Venous Thrombosis After TKA, run by Shanghai Hengrui Pharmaceutical 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 5 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: stopped early, as of the sponsor's last update on 17 Nov 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 was stopped early (reason given: Adjustment of the sponsor's R\&D strategy). Results are not available in the source record.
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?
Number of patients with confirmed composite endpoint (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 17 Nov 2025.