Not provided
Not provided
Not provided
Not provided
Not provided
Adjustment of the sponsor's R&D strategy
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | SHR2285 tablet; dose 1 |
|
| Treatment group 2 | Experimental | SHR2285 tablet; dose 2 |
|
| Treatment group 3 | Experimental | SHR2285 tablet; dose 3 |
|
| Treatment group 4 | Experimental | SHR2285 tablet; dose 4 |
|
| Treatment group 5 | Active Comparator | Enoxaparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2285 tablet | Drug | SHR2285 tablet; dose 1, for 12 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 12 |
| Number of patients with composite bleeding | Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events | Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Day 12 |
| Number of patients with composite venous thromboembolic events (VTE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SHR2285 tablets compared with Enoxaparin
Not provided
Not provided
Not provided
| SHR2285 tablet |
| Drug |
SHR2285 tablet; dose 2, for 12 days |
|
| SHR2285 tablet | Drug | SHR2285 tablet; dose 3, for 12 days |
|
| SHR2285 tablet | Drug | SHR2285 tablet; dose 4, for 12 days |
|
| Enoxaparin | Drug | Enoxaparin, for 12 days |
|
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 |
| Day 1 to Day 42 |
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided