Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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 and target biomarkers over time after administration of a gene-editing therapy.
Timepoint [1] 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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2038
Actual
Sample size
Target
44
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06112327
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
LTF001@vervetx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06112327