Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06112327
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-27
First Post:
2023-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Participants Dosed with an Investigational Gene Editing Therapy for Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2039-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and other events of interest using CTCAE 5.0 to assess the long-term safety of gene-editing therapies.', 'timeFrame': 'up to 15 years', 'description': 'To assess the long-term safety of gene-editing therapies, the following will be assessed:\n\nIncidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and any CTCAE grade 3 or higher AEs.'}], 'secondaryOutcomes': [{'measure': 'Percent and absolute change from baseline of lipid concentrations over time after administration of a gene-editing therapy.', 'timeFrame': 'up to 15 years', 'description': 'Blood samples will be collected to assess percent change from baseline in lipid concentrations (including LDL-C).'}, {'measure': 'Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.', 'timeFrame': 'up to 15 years', 'description': 'Blood samples will be collected to assess percent change from baseline in target biomarkers.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LTF-001', 'Cardiovascular Disease', 'Gene Editing', 'Familial Hypercholesterolemia', 'Base Editing'], 'conditions': ['Atherosclerotic Cardiovascular Disease', 'Heterozygous Familial Hypercholesterolemia', 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who received an investigational gene-editing therapy developed by the sponsor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. A participant has completed or discontinued from a Verve sponsored clinical study in which they received at least one dose of study drug.\n2. A participant has provided informed consent for LTF-001.\n\nExclusion Criteria: N/A'}, 'identificationModule': {'nctId': 'NCT06112327', 'briefTitle': 'Long-term Follow-up of Participants Dosed with an Investigational Gene Editing Therapy for Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Verve Therapeutics, Inc.'}, 'officialTitle': 'Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants with or At High Risk for Cardiovascular Disease', 'orgStudyIdInfo': {'id': 'LTF-001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Clinical Study Center', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Clinical Study Center', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Clinical Study Center', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verve Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}