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

Phase 2

• Conditions: Prevention of Venous Thrombosis After TKA
• Interventions: Drug: SHR2285 tablet; Drug: Enoxaparin

• Registration Number: NCT05203705
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-24
• Status Verified: 2022-03
• Study Start: 2022-03-08
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21
• Primary Completion: 2023-04-07
• Study Completion: 2023-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);
2. Scheduled to undergo elective unilateral total knee arthroplasty;
3. Males or females aged 40-75 years.

Exclusion Criteria

1. Weighing less than 40 kg or greater than 135 kg;
2. Allergic to contrast agents rendering the patient unable to undergo venous angiography of the lower extremities; allergic to enoxaparin or any of the ingredients listed in the package insert thereof; allergic to the investigational product or any of the ingredients thereof;
3. With malignant tumors that still require medical intervention; except for radically treated non-melanoma skin cancer, basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ;
4. With a history of major liver disease within 1 year;
5. With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1	SHR2285 tablet	SHR2285 tablet; dose 1
Treatment group 2	SHR2285 tablet	SHR2285 tablet; dose 2
Treatment group 3	SHR2285 tablet	SHR2285 tablet; dose 3
Treatment group 4	SHR2285 tablet	SHR2285 tablet; dose 4
Treatment group 5	Enoxaparin	Enoxaparin

Primary Outcome Measures

Name	Time	Method
Number of patients with confirmed composite endpoint	Day 12	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
Number of patients with composite bleeding	Day 12	Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events

Secondary Outcome Measures

Name	Time	Method
Number of patients with composite venous thromboembolic events (VTE)	Day 1 to Day 42	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

Trial Locations

Locations (1)

Perking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China