Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05203705
Status:
TERMINATED
Last Update Posted:
2025-11-17
First Post:
2022-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR2285 tablets compared with Enoxaparin'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': "Adjustment of the sponsor's R\\&D strategy", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with confirmed composite endpoint', 'timeFrame': 'Day 12', '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'}, {'measure': 'Number of patients with composite bleeding', 'timeFrame': 'Day 12', 'description': 'Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events'}], 'secondaryOutcomes': [{'measure': 'Number of patients with composite venous thromboembolic events (VTE)', 'timeFrame': 'Day 1 to Day 12', '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'}, {'measure': 'Number of patients with composite venous thromboembolic events (VTE)', 'timeFrame': 'Day 1 to Day 42', '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Venous Thrombosis After TKA']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);\n2. Scheduled to undergo elective unilateral total knee arthroplasty;\n3. Males or females aged 40-75 years.\n\nExclusion Criteria:\n\n1. Weighing less than 40 kg or greater than 135 kg;\n2. 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;\n3. 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;\n4. With a history of major liver disease within 1 year;\n5. With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.'}, 'identificationModule': {'nctId': 'NCT05203705', 'briefTitle': 'Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SHR2285-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group 1', 'description': 'SHR2285 tablet; dose 1', 'interventionNames': ['Drug: SHR2285 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 2', 'description': 'SHR2285 tablet; dose 2', 'interventionNames': ['Drug: SHR2285 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 3', 'description': 'SHR2285 tablet; dose 3', 'interventionNames': ['Drug: SHR2285 tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 4', 'description': 'SHR2285 tablet; dose 4', 'interventionNames': ['Drug: SHR2285 tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group 5', 'description': 'Enoxaparin', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'SHR2285 tablet', 'type': 'DRUG', 'description': 'SHR2285 tablet; dose 1, for 12 days', 'armGroupLabels': ['Treatment group 1']}, {'name': 'SHR2285 tablet', 'type': 'DRUG', 'description': 'SHR2285 tablet; dose 2, for 12 days', 'armGroupLabels': ['Treatment group 2']}, {'name': 'SHR2285 tablet', 'type': 'DRUG', 'description': 'SHR2285 tablet; dose 3, for 12 days', 'armGroupLabels': ['Treatment group 3']}, {'name': 'SHR2285 tablet', 'type': 'DRUG', 'description': 'SHR2285 tablet; dose 4, for 12 days', 'armGroupLabels': ['Treatment group 4']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Enoxaparin, for 12 days', 'armGroupLabels': ['Treatment group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Perking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}