Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 2:30 PM
Study NCT ID:
NCT06549608
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605992', 'term': 'MYK-461'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 685}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant demographics', 'timeFrame': 'Baseline'}, {'measure': 'Participant clinical characteristics', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Dose regimen of mavacamten treatment', 'timeFrame': 'Every 3-months up to 14 months'}, {'measure': 'Titration patterns of mavacamten treatment', 'timeFrame': 'Up to 14 months'}, {'measure': 'Mavacamten treatment duration', 'timeFrame': 'Up to 14 months'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertrophic cardiomyopathy'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the Bristol-Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program in Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants in Canada diagnosed with hypertrophic cardiomyopathy (oHCM) receiving mavacamten treatment as part of the BMS-sponsored CAMZYOS Patient Support Program', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ≥18 years of age.\n* Participants who have initiated mavacamten as part of routine clinical care, through the BMS-sponsored CAMZYOS Patient Support Program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.\n* Participants who consented to the use of their de-identified data, generated from information collected in the course of the program.\n\nExclusion Criteria:\n\n• There are no exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT06549608', 'briefTitle': 'A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Patient Characteristics and Treatment Duration of Mavacamten Obstructive HCM Patient Support Program in Canada: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'CV027-1187'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults participants treated with mavacamten', 'description': 'Participants with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care.', 'interventionNames': ['Drug: Mavacamten']}], 'interventions': [{'name': 'Mavacamten', 'type': 'DRUG', 'description': 'As per product label', 'armGroupLabels': ['Adults participants treated with mavacamten']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}