Status:
TERMINATED
Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Prevention of Venous Thrombosis After TKA
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05203705
Start Date
March 7 2022
End Date
March 14 2023
Last Update
November 17 2025
Active Locations (1)
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1
Perking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730