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SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05752461
Collaborator
(none)
316
Enrollment
4
Arms
18.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR-2004 injection
  • Drug: SHR-2004 injection
  • Drug: SHR-2004 injection
  • Drug: Enoxaparin sodium injection
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
316 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
SHR-2004 injection compared with Enoxaparin sodium injectionSHR-2004 injection compared with Enoxaparin sodium injection
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multicenter, Randomized, Active-comparator-controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of a Single Subcutaneous Injection of SHR-2004 in Patients Undergoing Elective Unilateral Total Knee Arthroplasty
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Jun 15, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A: SHR-2004 injection

Drug: SHR-2004 injection
low dose subcutaneous injection once
Experimental: Treatment group B: SHR-2004 injection

Drug: SHR-2004 injection
medium dose subcutaneous injection once
Experimental: Treatment group C: SHR-2004 injection

Drug: SHR-2004 injection
high dose subcutaneous injection once
Active Comparator: Treatment group D: Enoxaparin sodium injection

Drug: Enoxaparin sodium injection
40 mg administered as subcutaneous injection once daily

Outcome Measures

Primary Outcome Measures

  1. Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Primary efficacy outcome） [Day 12]

  2. Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome） [Day 12]

Secondary Outcome Measures

  1. Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral CT venography, confirmed symptomatic DVT, non-fatal PE and all-cause death（Secondary efficacy endpoint） [Day 85]

  2. Incidence of composite endpoint of any bleeding（Secondary safety endpoint） [Day 12]

  3. Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint） [Day 85]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent

  2. Scheduled to undergo elective unilateral total knee arthroplayts (TKA)

  3. Male or female(≥ 40 years old and < 80 years old)

Exclusion Criteria:

  1. Unable to receive CT angiography of both lower limbs;

  2. Malignant tumor within one year of the screening ;

  3. History of venous thromboembolism;

  4. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;

  5. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding

  6. Any of the laboratory test indicators meets the following criteria:

①estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 ;

②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal value (ULN);

③total bilirubin was > 2 times, etc

  1. History of drug abuse;

  2. Pregnant or lactating women

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Suncadia Pharmaceuticals Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Suncadia Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT05752461
Other Study ID Numbers:
  • SHR-2004-201
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Enoxaparin
Enoxaparin sodium

Study Results

No Results Posted as of Mar 2, 2023