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This study is designed to evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational product arm | Experimental |
| |
| Positive control arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2004 | Drug | Investigational product arm: SHR-2004 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint: The incidence rate of VTE from the first medication to the end of the treatment period (Day 28) | including asymptomatic deep vein thrombosis (DVT) (confirmed by bilateral lower limb venous compression ultrasound), objectively confirmed symptomatic DVT, and objectively confirmed non-fatal. The composite endpoint of pulmonary thromboembolism (PE) and VTE-related death. | up to Day 28 |
| The composite endpoint incidence rate of major bleeding and clinically relevant non-major bleeding events as defined by the International Society on Thrombosis and Haemostasis (ISTH) from the first dose to the end of the treatment period | Primary safety endpoints | up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of each component of the primary efficacy endpoint | Secondary efficacy endpoint | up to Day 28 |
| Secondary efficacy endpoint: The total VTE incidence rate from the first medication to the end of follow-up (D85) and the incidence rate of each component event |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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1:1 randomized and paralleled 2 arms: Investigational product arm, Positive control arm
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| Enoxaparin Sodium Injection; Rivaroxaban Tablets |
| Drug |
Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets |
|
including asymptomatic DVT (confirmed by bilateral lower limb venous compression color ultrasound), objectively confirmed symptomatic DVT, and objectively confirmed non-fatal. The composite endpoint of sexual PE and VTE-related death. |
| up to Day 85 |
| The event rate of each component of the primary safety endpoint | Secondary safety endpoints | up to Day 28 |
| The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of the treatment period | Secondary safety endpoints | up to Day 28 |
| The composite endpoint incidence rate and each component event rate of major bleeding and clinically relevant non-major bleeding events that meet the definition of ISTH from the first medication to the end of follow-up | Secondary safety endpoints | up to Day 85 |
| The incidence of any bleeding events (including minor bleeding events) from the first dose to the end of follow-up | Secondary safety endpoints | up to Day 85 |
| The incidence and severity of adverse events. | Secondary safety endpoints | up to Day 85 |
| ID | Term |
|---|---|
| C000711671 | enoxaparin sodium |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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