Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-2004 injection | Experimental |
| |
| Treatment group B: SHR-2004 injection | Experimental |
| |
| Treatment group C: SHR-2004 injection | Experimental |
| |
| Treatment group D: Enoxaparin sodium injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2004 injection | Drug | low dose subcutaneous injection once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 12 | |
| Incidence of composite endpoint of major and clinically relevant non-major bleeding(Primary safety outcome) | Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 85 | |
| Incidence of composite endpoint of any bleeding(Secondary safety endpoint) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SHR-2004 injection compared with Enoxaparin sodium injection
Not provided
Not provided
Not provided
Not provided
| SHR-2004 injection |
| Drug |
medium dose subcutaneous injection once |
|
| SHR-2004 injection | Drug | high dose subcutaneous injection once |
|
| Enoxaparin sodium injection | Drug | 40 mg administered as subcutaneous injection once daily |
|
| Day 12 |
| Incidence of composite endpoint of major and clinically relevant non-major bleeding(Secondary safety endpoint) | Day 85 |
| ID | Term |
|---|---|
| C000711671 | enoxaparin sodium |
Not provided
Not provided
Not provided