Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-08 @ 4:56 AM
Study NCT ID:
NCT06516068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2024-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver", 'timeFrame': 'After 12 weeks of HRS-1893 treatment'}], 'secondaryOutcomes': [{'measure': 'Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in LVEF', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in LVOT-VTI', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in LV-FS', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in LV-GLS', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in Rest LVOT-G', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in Valsalva LVOT-G', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in cardiac troponin', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in NT-proBNP', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Proportion of participants with ≥ 1 class improvement in NYHA Functional Class', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)', 'timeFrame': 'Through study completion, an average of 68 weeks'}, {'measure': 'plasma concentration of HRS-1893', 'timeFrame': 'Through study completion, an average of 68 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-85 years old, gender unlimited;\n2. The diagnosis was obstructive hypertrophic cardiomyopathy.\n3. Echocardiographic laboratory tests showed LVEF≥60%;\n4. No previous left ventricular systolic dysfunction at any time (LVEF \\< 45%);\n5. Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.\n\nExclusion Criteria:\n\n1. Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM);\n2. Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF \\< 45%);\n3. Previous history of aortic stenosis or subaortic fixed stenosis;"}, 'identificationModule': {'nctId': 'NCT06516068', 'briefTitle': 'A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.', 'orgStudyIdInfo': {'id': 'HRS-1893-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-1893', 'interventionNames': ['Drug: HRS-1893']}], 'interventions': [{'name': 'HRS-1893', 'type': 'DRUG', 'description': 'HRS-1893', 'armGroupLabels': ['HRS-1893']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}