Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT06816251
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'Up to 14 weeks.'}, {'measure': 'The incidence of left ventricular ejection fraction (LVEF) < 50%', 'timeFrame': 'Up to 14 weeks.'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen uptake (pVO2) value', 'timeFrame': 'About 12 weeks.'}, {'measure': 'The cardiac troponin value', 'timeFrame': 'About 12 weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-obstructive Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-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 (including boundary value), male or female.\n2. Body mass index \\< 35 kg/m2.\n3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.\n4. Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.\n5. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.\n\nExclusion Criteria:\n\n1. Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.\n2. Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.\n3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.\n4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.\n5. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.'}, 'identificationModule': {'nctId': 'NCT06816251', 'briefTitle': 'A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'HRS-1893-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-1893 low-dose group', 'interventionNames': ['Drug: HRS-1893']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HRS-1893 placebo low-dose group', 'interventionNames': ['Drug: HRS-1893 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-1893 high-dose group', 'interventionNames': ['Drug: HRS-1893']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HRS-1893 placebo high-dose group', 'interventionNames': ['Drug: HRS-1893 placebo']}], 'interventions': [{'name': 'HRS-1893', 'type': 'DRUG', 'description': 'HRS-1893 tablet.', 'armGroupLabels': ['HRS-1893 high-dose group', 'HRS-1893 low-dose group']}, {'name': 'HRS-1893 placebo', 'type': 'DRUG', 'description': 'HRS-1893 tablet placebo.', 'armGroupLabels': ['HRS-1893 placebo high-dose group', 'HRS-1893 placebo low-dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lianming Kang', 'role': 'CONTACT', 'email': 'lianmingkang@126.com', 'phone': '010-88396870'}, {'name': 'Lianming Kang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jianhong Lv', 'role': 'CONTACT', 'email': 'jianhong.lv.jl9@hengrui.com', 'phone': '18921102884'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}