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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

Primary Purpose

Prevention of Venous Thrombosis After TKA

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR2285 tablet
SHR2285 tablet
SHR2285 tablet
SHR2285 tablet
Enoxaparin
Sponsored by
Shanghai Hengrui Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prevention of Venous Thrombosis After TKA

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Perking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Treatment group 1

Treatment group 2

Treatment group 3

Treatment group 4

Treatment group 5

Arm Description

SHR2285 tablet; dose 1

SHR2285 tablet; dose 2

SHR2285 tablet; dose 3

SHR2285 tablet; dose 4

Enoxaparin

Outcomes

Primary Outcome Measures

Number of patients with confirmed composite endpoint
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
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events

Secondary Outcome Measures

Number of patients with composite venous thromboembolic events (VTE)
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
Number of patients with composite venous thromboembolic events (VTE)
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

Full Information

First Posted
January 20, 2022
Last Updated
March 18, 2022
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05203705
Brief Title
Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
April 7, 2023 (Anticipated)
Study Completion Date
May 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Venous Thrombosis After TKA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
SHR2285 tablets compared with Enoxaparin
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group 1
Arm Type
Experimental
Arm Description
SHR2285 tablet; dose 1
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
SHR2285 tablet; dose 2
Arm Title
Treatment group 3
Arm Type
Experimental
Arm Description
SHR2285 tablet; dose 3
Arm Title
Treatment group 4
Arm Type
Experimental
Arm Description
SHR2285 tablet; dose 4
Arm Title
Treatment group 5
Arm Type
Active Comparator
Arm Description
Enoxaparin
Intervention Type
Drug
Intervention Name(s)
SHR2285 tablet
Intervention Description
SHR2285 tablet; dose 1, for 12 days
Intervention Type
Drug
Intervention Name(s)
SHR2285 tablet
Intervention Description
SHR2285 tablet; dose 2, for 12 days
Intervention Type
Drug
Intervention Name(s)
SHR2285 tablet
Intervention Description
SHR2285 tablet; dose 3, for 12 days
Intervention Type
Drug
Intervention Name(s)
SHR2285 tablet
Intervention Description
SHR2285 tablet; dose 4, for 12 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Enoxaparin, for 12 days
Primary Outcome Measure Information:
Title
Number of patients with confirmed composite endpoint
Description
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
Time Frame
Day 12
Title
Number of patients with composite bleeding
Description
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
Number of patients with composite venous thromboembolic events (VTE)
Description
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
Time Frame
Day 1 to Day 12
Title
Number of patients with composite venous thromboembolic events (VTE)
Description
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
Time Frame
Day 1 to Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Jin
Phone
+86 18818260161
Email
Yun.jin.yj1@hengrui.com
Facility Information:
Facility Name
Perking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Deng, Doctor
Phone
+86- 13366200018
Email
drwengxsh@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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

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