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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06112327
Registration number
NCT06112327
Ethics application status
Date submitted
12/10/2023
Date registered
1/11/2023
Date last updated
1/11/2023
Titles & IDs
Public title
Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease
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Scientific title
Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk for Cardiovascular Disease
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Secondary ID [1]
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LTF-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease
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Heterozygous Familial Hypercholesterolemia
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Hypercholesterolemia
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Metabolic and Endocrine
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0
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Other metabolic disorders
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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To assess the long-term safety of gene-editing therapies, the following will be assessed:
Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs) and any CTCAE grade 3 or higher AEs.
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Timepoint [1]
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up to 15 years
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Secondary outcome [1]
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Percent and absolute change from baseline of lipid concentrations and target biomarkers over time after administration of a gene-editing therapy.
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Assessment method [1]
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Blood samples will be collected to assess percent change from baseline in lipid concentrations (including LDL-C) and target biomarkers.
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Timepoint [1]
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up to 15 years
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. A participant has completed or discontinued from a Verve sponsored clinical study in
which they received at least one dose of study drug.
2. A participant has provided informed consent for LTF-001.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
N/A
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/04/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2038
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Actual
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Sample size
Target
44
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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United Kingdom
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State/province [3]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Verve Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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, including time in both the interventional
study and study LTF-001.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06112327
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Clinical Operations at Verve Therapeutics
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Address
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Country
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Phone
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+1 781-970-6833
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06112327
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