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

Hengrui Medicine

Status and phase: Terminated; Phase 2

Conditions: Prevention of Venous Thrombosis After TKA

Treatments: Drug: SHR2285 tablet; Drug: Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05203705

SHR2285-201

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 5 patient groups

Treatment group 1

Experimental group

Description:

SHR2285 tablet; dose 1

Treatment:

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Treatment group 2

Experimental group

Description:

SHR2285 tablet; dose 2

Treatment:

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Treatment group 3

Experimental group

Description:

SHR2285 tablet; dose 3

Treatment:

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Treatment group 4

Experimental group

Description:

SHR2285 tablet; dose 4

Treatment:

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Drug: SHR2285 tablet

Treatment group 5

Active Comparator group

Description:

Enoxaparin

Treatment:

Drug: Enoxaparin