Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-03-23 @ 7:02 PM
Study NCT ID:
NCT05752461
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR-2004 injection compared with Enoxaparin sodium injection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-02-22', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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'}, {'measure': 'Incidence of composite endpoint of major and clinically relevant non-major bleeding（Primary safety outcome）', 'timeFrame': 'Day 12'}], 'secondaryOutcomes': [{'measure': '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'}, {'measure': 'Incidence of composite endpoint of any bleeding（Secondary safety endpoint）', 'timeFrame': 'Day 12'}, {'measure': 'Incidence of composite endpoint of major and clinically relevant non-major bleeding（Secondary safety endpoint）', 'timeFrame': 'Day 85'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Venous Thromboembolism After Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand the research procedures and methods, volunteer to participate in the study, and sign the informed consent\n2. Scheduled to undergo elective unilateral total knee arthroplayts (TKA)\n3. Male or female(≥ 40 years old and \\< 80 years old)\n\nExclusion Criteria:\n\n1. Unable to receive CT angiography of both lower limbs;\n2. Malignant tumor within one year of the screening ;\n3. History of venous thromboembolism;\n4. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;\n5. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding\n6. Any of the laboratory test indicators meets the following criteria:\n\n ①estimated Glomerular Filtration Rate \\< 60 mL/min/1.73m2 ;\n\n ②Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 times the upper limit of normal value (ULN);\n\n ③total bilirubin was \\> 2 times, etc\n7. History of drug abuse;\n8. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT05752461', 'briefTitle': 'SHR-2004 for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Suncadia Pharmaceuticals Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SHR-2004-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A: SHR-2004 injection', 'interventionNames': ['Drug: SHR-2004 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B: SHR-2004 injection', 'interventionNames': ['Drug: SHR-2004 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group C: SHR-2004 injection', 'interventionNames': ['Drug: SHR-2004 injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group D: Enoxaparin sodium injection', 'interventionNames': ['Drug: Enoxaparin sodium injection']}], 'interventions': [{'name': 'SHR-2004 injection', 'type': 'DRUG', 'description': 'low dose subcutaneous injection once', 'armGroupLabels': ['Treatment group A: SHR-2004 injection']}, {'name': 'SHR-2004 injection', 'type': 'DRUG', 'description': 'medium dose subcutaneous injection once', 'armGroupLabels': ['Treatment group B: SHR-2004 injection']}, {'name': 'SHR-2004 injection', 'type': 'DRUG', 'description': 'high dose subcutaneous injection once', 'armGroupLabels': ['Treatment group C: SHR-2004 injection']}, {'name': 'Enoxaparin sodium injection', 'type': 'DRUG', 'description': '40 mg administered as subcutaneous injection once daily', 'armGroupLabels': ['Treatment group D: Enoxaparin sodium injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Suncadia Pharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}