Knee Arthroplasty, Total
Conditions
Brief 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).
Interventions
DRUGEnoxaparin
40 mg enoxaparin administered as subcutaneous injection once daily
DRUGKN060 Low
Single dose of KN060 administered as intravenous infusion
DRUGKN060 Middle
Single dose of KN060 administered as intravenous infusion
DRUGKN060 Hight
Single dose of KN060 administered as intravenous infusion
Sponsors
Suzhou Alphamab Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged between 18 and 75 years old (including the cut-off value); 2. undergoing unilateral Total Knee Arthroplasty (TKA); 3. Voluntarily participate in the study and sign a written informed consent;
Exclusion criteria
1. There is a high risk of bleeding or abnormal bleeding related indicators: 2. Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease. 3. Acute myocardial infarction or ischemic stroke occurred within 6 months before screening. 4. Presence of malignant tumors or history of malignant tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 14 days | DVT - Deep vein thrombosis / PE - Pulmonary embolism. All suspected events were reviewed and classified by the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse event/adverse drug reaction | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| Plasma Concentration of KN060 | Up to 100 days | — |
| Pharmacodynamics index: Changes of plasma concentration of Free FⅪ from baseline; | Up to 100 days | Free FⅪ: Free Factor XI; Factor XI is a clotting factor. |
| Pharmacodynamics index: Changes of FⅪ activity from baseline; | Up to 100 days | FⅪ: Factor XI; Factor XI is a clotting factor. |
| Pharmacodynamics index: Changes of APTT from baseline; | Up to 100 days | APTT: activated partial thromboplastin time; |
| Incidence of composite endpoint of major and clinically relevant non-major bleeding | Up to 14 days | All suspected events were reviewed and classified by the investigator |
| Incidence of clinically relevant non-major bleeding | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| Incidence of symptomatic DVT, non-fatal PE | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| Incidence of fatal PE | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| Incidence of unexplained death for which PE cannot be excluded | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| Incidence of bleeding | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| Incidence of major bleeding | Up to 14 \35\100 days | All suspected events were reviewed and classified by the investigator |
| 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 | Up to 35\100 days | All suspected events were reviewed and classified by the investigator |
Countries
China
Outcome results
None listed