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

NCT05203705 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-11-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2023-03-14
Completion
2023-03-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203705 on ClinicalTrials.gov