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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
225
Investigational product arm: SHR-2004
Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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.
Time frame: 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
Time frame: up to Day 28
The event rate of each component of the primary efficacy endpoint
Secondary efficacy endpoint
Time frame: 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
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.
Time frame: up to Day 85
The event rate of each component of the primary safety endpoint
Secondary safety endpoints
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: up to Day 85
The incidence and severity of adverse events.
Secondary safety endpoints
Time frame: up to Day 85