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

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.

Study Overview

• Status: Terminated
• Conditions: Prevention of Venous Thrombosis After TKA
• Intervention / Treatment: Drug: SHR2285 tablet; Drug: SHR2285 tablet; Drug: SHR2285 tablet; Drug: SHR2285 tablet; Drug: Enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Perking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1; SHR2285 tablet; dose 1	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
Experimental: Treatment group 2; SHR2285 tablet; dose 2	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
Experimental: Treatment group 3; SHR2285 tablet; dose 3	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
Experimental: Treatment group 4; SHR2285 tablet; dose 4	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
Active Comparator: Treatment group 5; Enoxaparin	Drug: Enoxaparin; Enoxaparin, for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with confirmed composite endpoint	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	Day 12
Number of patients with composite bleeding	Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events	Day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with composite venous thromboembolic events (VTE)	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	Day 1 to Day 12
Number of patients with composite venous thromboembolic events (VTE)	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	Day 1 to Day 42

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Enoxaparin
• Other Study ID Numbers: SHR2285-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No