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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06112327




Registration number
NCT06112327
Ethics application status
Date submitted
12/10/2023
Date registered
1/11/2023

Titles & IDs
Public title
Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease
Scientific title
Long-term Follow-up Study of Investigational Gene-editing Therapies in Participants With or at High Risk for Cardiovascular Disease
Secondary ID [1] 0 0
LTF-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Heterozygous Familial Hypercholesterolemia 0 0
Hypercholesterolemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
up to 15 years
Secondary outcome [1] 0 0
Percent and absolute change from baseline of lipid concentrations over time after administration of a gene-editing therapy.
Timepoint [1] 0 0
up to 15 years
Secondary outcome [2] 0 0
Percent and absolute change from baseline of target biomarkers over time after administration of a gene-editing therapy.
Timepoint [2] 0 0
up to 15 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2038
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
United Kingdom
State/province [3] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Verve Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operations at Verve Therapeutics
Address 0 0
Country 0 0
Phone 0 0
+1 781-970-6833
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06112327