SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
- 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
- Short title
- SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-06-25
- First posted
- 2023-03-02
- Registry last updated
- 2025-01-20
- Primary completion date
- 2024-04-12
- Start date
- 2023-04-12
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05752461
- ClinicalTrials.gov ID
- NCT05752461
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- No masking
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）
Timeframe: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）
Timeframe: Day 12
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）
Timeframe: Day 85
Incidence of composite endpoint of any bleeding（Secondary safety endpoint）
Timeframe: Day 12
Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）
Timeframe: Day 85
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent
- Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
- Male or female(≥ 40 years old and < 80 years old)
-
Unable to receive CT angiography of both lower limbs;
-
Malignant tumor within one year of the screening ;
-
History of venous thromboembolism;
-
Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
-
Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding
-
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
-
History of drug abuse;
-
Pregnant or lactating women
- Xiangya Hospital Central South UniversityChangsha, China