Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 12:16 PM
Study NCT ID:
NCT06116968
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events observed during dosing of Aficamten in patients with symptomatic oHCM.', 'timeFrame': 'through study completion, at least 1 year', 'description': '* Patient incidence of reported adverse events (AEs)\n* Patient incidence of reported serious adverse events (SAEs)\n* Patient incidence of left ventricular ejection fraction (LVEF) \\< 40 %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Completion of a Cytokinetics trial investigating CK-3773274\n2. LVEF ≥55% at the Screening Visit\n\nExclusion Criteria:\n\n1. Has participated in another investigational device or drug study or received an investigational device or drug \\<1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.\n2. Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \\<30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) \\<100 bpm and/or rhythm is stable \\>30 days.\n3. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).\n4. Had a confirmed LVEF \\<40% with an associated dose interruption during participation in a prior study with aficamten.\n5. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.\n6. Has received treatment with mavacamten.'}, 'identificationModule': {'nctId': 'NCT06116968', 'briefTitle': 'An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corxel Pharmaceuticals'}, 'officialTitle': 'An Open-Label Study of Aficamten for Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'JX01003'}, 'secondaryIdInfos': [{'id': 'CTR20233249', 'type': 'REGISTRY', 'domain': 'China Center for Drug Evaluation(CDE)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aficamten', 'description': 'Patients in this arm take daily dose of Aficamten. Each patient will start at the lowest dose (5 mg) in the pre-specified dose range and undergo dose titration up to a maximum of 20 mg.', 'interventionNames': ['Drug: Aficamten']}], 'interventions': [{'name': 'Aficamten', 'type': 'DRUG', 'otherNames': ['CK-3773274'], 'description': '5-20mg', 'armGroupLabels': ['Aficamten']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Chao-yang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fuwai Hospital, CAMS & PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengdu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 33.99934, 'lon': 105.19994}}, {'city': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Dong', 'role': 'CONTACT', 'email': 'Cherry.dong@jixingbio.com', 'phone': '8613512538014'}], 'overallOfficials': [{'name': 'Yuhui Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PUMCH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corxel Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}