NCT05203705

Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty

Efficacy and Safety of SHR2285 Tablets Following Multiple Oral Administrations in Patients Undergoing Elective Total Knee Arthroplasty: a Multicenter, Randomized, Positive-controlled Phase II Clinical Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prevention of Venous Thrombosis After TKA

Interventions

Type	Name	Description
DRUG	SHR2285 tablet	SHR2285 tablet; dose 1, for 12 days
DRUG	SHR2285 tablet	SHR2285 tablet; dose 2, for 12 days
DRUG	SHR2285 tablet	SHR2285 tablet; dose 3, for 12 days
DRUG	SHR2285 tablet	SHR2285 tablet; dose 4, for 12 days
DRUG	Enoxaparin	Enoxaparin, for 12 days

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-03-14
• Completion: 2023-03-14
• First posted: 2022-01-24
• Last updated: 2025-11-17

Locations

1 site across 1 country: China