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

NCT05203705 | Terminated Phase 2

• 1 other identifier: SHR2285-201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention of Venous Thrombosis After TKA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of patients with composite venous thromboembolic events (VTE)

  Day 1 to Day 12

• Number of patients with composite venous thromboembolic events (VTE)

  Day 1 to Day 42

Study Arms (5)

Treatment group 1

EXPERIMENTAL

SHR2285 tablet; dose 1

Drug: SHR2285 tablet

Treatment group 2

EXPERIMENTAL

SHR2285 tablet; dose 2

Drug: SHR2285 tablet

Treatment group 3

EXPERIMENTAL

SHR2285 tablet; dose 3

Drug: SHR2285 tablet

Treatment group 4

EXPERIMENTAL

SHR2285 tablet; dose 4

Drug: SHR2285 tablet

Treatment group 5

ACTIVE COMPARATOR

Enoxaparin

Drug: Enoxaparin

Interventions

SHR2285 tablet DRUG

SHR2285 tablet; dose 1, for 12 days

Treatment group 1

Enoxaparin DRUG

Enoxaparin, for 12 days

Treatment group 5

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Weighing less than 40 kg or greater than 135 kg;
• 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;
• 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;
• With a history of major liver disease within 1 year;
• With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Perking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR2285 tablets compared with Enoxaparin

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: January 24, 2022
• Study Start: March 7, 2022
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)