Knee Arthroplasty, TotalPhase 2NCT06180889
Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
A Phase 2 study testing Enoxaparin, KN060 Low and KN060 Middle in people with Knee Arthroplasty, Total, run by Suzhou Alphamab Co., Ltd. at 1 site in China.
Trial summary
This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Enoxaparin, KN060 Low and KN060 Middle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 15 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged between 18 and 75 years old (including the cut-off value);
- undergoing unilateral Total Knee Arthroplasty (TKA);
- Voluntarily participate in the study and sign a written informed consent;
Who cannot join
- There is a high risk of bleeding or abnormal bleeding related indicators:
- Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.
- Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.
- Presence of malignant tumors or history of malignant tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Active-comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of Different Doses of KN060 for the Prevention of Venous Thromboembolism in Patients Undergoing Unilateral Total Knee Arthroplasty.
This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Enoxaparin, KN060 Low, KN060 Middle, KN060 Hight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
40 mg enoxaparin administered as subcutaneous injection once daily
KN060 LowDrug
Single dose of KN060 administered as intravenous infusion
KN060 MiddleDrug
Single dose of KN060 administered as intravenous infusion
KN060 HightDrug
Single dose of KN060 administered as intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Active comparator | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery. Receives: Drug: Enoxaparin |
| KN060 Low (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery. Receives: Drug: KN060 Low |
| KN060 Middle (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery. Receives: Drug: KN060 Middle |
| KN060 Hight (post-surgery) | Experimental | Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery. Receives: Drug: KN060 Hight |
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 venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator
Measured: Up to 14 days
Secondary outcomes (14)
Incidence of composite endpoint of major and clinically relevant non-major bleeding
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 days
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
All suspected events were reviewed and classified by the investigator
Measured: Up to 35\100 days
Incidence of symptomatic DVT, non-fatal PE
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Incidence of fatal PE
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Incidence of unexplained death for which PE cannot be excluded
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding
All suspected events were reviewed and classified by the investigator
Measured: Up to 35\100 days
Incidence of bleeding
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Incidence of major bleeding
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Incidence of clinically relevant non-major bleeding
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Incidence of treatment emergent adverse event/adverse drug reaction
All suspected events were reviewed and classified by the investigator
Measured: Up to 14 \35\100 days
Plasma Concentration of KN060
Measured: Up to 100 days
Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline;
Free FⅪ: Free Factor XI; Factor XI is a clotting factor.
Measured: Up to 100 days
Pharmacodynamics index: Changes of FⅪ activity from baseline;
FⅪ: Factor XI; Factor XI is a clotting factor.
Measured: Up to 100 days
Pharmacodynamics index: Changes of APTT from baseline;
APTT: activated partial thromboplastin time;
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start20 Dec 2023
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Alphamab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianlong Zhang, Doctor, Principal investigator, Shanghai 6th People's HospitalFeng Yin, Doctor, Principal investigator, Shanghai East Hospital of Tongji UniversityZhenjun Yao, Doctor, Principal investigator, Fudan UniversityShijun Gao, Doctor, Principal investigator, Hebei Medical University Third HospitalJun Lu, Doctor, Principal investigator, Zhongda HospitalXinshe Zhou, Doctor, Principal investigator, The First Affiliated Hospital Of Bengbu Medicai CollegeRende Ning, Doctor, Principal investigator, Hefei First People's HospitalLidong Wu, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180889
- Sponsor's protocol ID
- KN060-A-201
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Active-comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of Different Doses of KN060 for the Prevention of Venous Thromboembolism in Patients Undergoing Unilateral Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT06180889
- Acronym / sponsor ID
- KN060-A-201
- Conditions
- Knee Arthroplasty, Total
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Suzhou Alphamab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 26 Dec 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.
This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Active comparator | Drug: EnoxaparinAdult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days post-surgery. |
| KN060 Low (post-surgery) | Experimental | Drug: KN060 LowAdult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 low dose once post-surgery. |
| KN060 Middle (post-surgery) | Experimental | Drug: KN060 MiddleAdult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 middle dose once post-surgery. |
| KN060 Hight (post-surgery) | Experimental | Drug: KN060 HightAdult patients who underwent Total Knee Arthroplasty (TKA) surgery and received KN060 hight dose once post-surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged between 18 and 75 years old (including the cut-off value);
- undergoing unilateral Total Knee Arthroplasty (TKA);
- Voluntarily participate in the study and sign a written informed consent;
Key exclusion criteria (4 listed)
- There is a high risk of bleeding or abnormal bleeding related indicators:
- Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease.
- Acute myocardial infarction or ischemic stroke occurred within 6 months before screening.
- Presence of malignant tumors or history of malignant tumors.
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 |
|---|---|---|
| Enoxaparin40 mg enoxaparin administered as subcutaneous injection once daily | Drug | Enoxaparin |
| KN060 LowSingle dose of KN060 administered as intravenous infusion | Drug | KN060 Low (post-surgery) |
| KN060 MiddleSingle dose of KN060 administered as intravenous infusion | Drug | KN060 Middle (post-surgery) |
| KN060 HightSingle dose of KN060 administered as intravenous infusion | Drug | KN060 Hight (post-surgery) |
Primary outcome
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
Time frame: Up to 14 days
DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator
14 secondary outcomes
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Time frame: Up to 14 days
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
Time frame: Up to 35\100 days
Incidence of symptomatic DVT, non-fatal PE
Time frame: Up to 14 \35\100 days
Incidence of fatal PE
Time frame: Up to 14 \35\100 days
Incidence of unexplained death for which PE cannot be excluded
Time frame: Up to 14 \35\100 days
Incidence of composite endpoint of major and clinically relevant non-major bleeding
Time frame: Up to 35\100 days
Incidence of bleeding
Time frame: Up to 14 \35\100 days
Incidence of major bleeding
Time frame: Up to 14 \35\100 days
Incidence of clinically relevant non-major bleeding
Time frame: Up to 14 \35\100 days
Incidence of treatment emergent adverse event/adverse drug reaction
Time frame: Up to 14 \35\100 days
Plasma Concentration of KN060
Time frame: Up to 100 days
Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline;
Time frame: Up to 100 days
Pharmacodynamics index: Changes of FⅪ activity from baseline;
Time frame: Up to 100 days
Pharmacodynamics index: Changes of APTT from baseline;
Time frame: Up to 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Xianlong Zhang, Doctor principal investigator
Shanghai 6th People's Hospital
Feng Yin, Doctor principal investigator
Shanghai East Hospital of Tongji University
Zhenjun Yao, Doctor principal investigator
Fudan University
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 Enoxaparin, KN060 Low and KN060 Middle in people with Knee Arthroplasty, Total, run by Suzhou Alphamab 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 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 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?
This study is still under way. Results are not available in the source record yet.
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 venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded (time frame: Up to 14 days). 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 Sep 2025.