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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05203705

Enrollment

Registered

2022-01-24

Start date

2022-03-07

Completion date

2023-03-14

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Venous Thrombosis After TKA

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.

Interventions

DRUGSHR2285 tablet

SHR2285 tablet; dose 1, for 12 days

DRUGEnoxaparin

Enoxaparin, for 12 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

SHR2285 tablets compared with Enoxaparin

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of patients with composite venous thromboembolic events (VTE)	Day 1 to 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) ,all-cause deaths

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026