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

  • STATUS
    Recruiting
  • End date
    May 13, 2023
  • participants needed
    500
  • sponsor
    Shanghai Hengrui Pharmaceutical Co., Ltd.
Updated on 7 April 2022

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.

Details
Condition Prevention of Venous Thrombosis After TKA
Treatment Enoxaparin, SHR2285 tablet
Clinical Study IdentifierNCT05203705
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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