Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
NCT Number: NCT06220123
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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Notify Me18 year and older
Female
Interventional
Phase 2
Hangzhou, Zhejiang, 310022, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Investigational product arm: SHR-2004
Positive control arm: Enoxaparin Sodium Injection + Rivaroxaban Tablets
Time frame: up to 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
Primary safety endpoints
Time frame: up to Day 28
Secondary efficacy endpoint
Time frame: up to Day 85
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 28
Secondary safety endpoints
Time frame: up to Day 28
Secondary safety endpoints
Time frame: up to Day 85
Secondary safety endpoints
Time frame: up to Day 85
Secondary safety endpoints
Time frame: up to Day 85
Secondary safety endpoints
Beijing Suncadia Pharmaceuticals Co., Ltd
Industry
A Multicenter, Randomized, Open-label, Active-controlled Phase II Clinical Study 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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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.