Long-term follow-up study of investigational gene-editing therapies for cardiovascular disease
Research type
Research Study
Full title
Long-term follow-up study of investigational gene-editing therapies in participants with or at high risk for cardiovascular disease
IRAS ID
1008367
Contact name
Matthew Schmidt
Contact email
Sponsor organisation
Verve Therapeutics, Inc.
ISRCTN Number
Not Applicable
Clinicaltrials.gov Identifier
TBD
Research summary
LTF-001 is a long-term follow-up study to evaluate participants with cardiovascular disease that have previously received a gene-editing therapy developed by the sponsor. Current European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines recommend long-term clinical monitoring and follow-up after treatment with investigational gene therapy products. Participants who have previously received a gene-editing therapy in a separate interventional study (ie, parent study) conducted by the sponsor will be entered into long-term follow-up following consent and there will be no administration of additional study drug. The purpose of this study is to help researchers understand the long-term safety of gene-editing therapy and evaluate how long the effects may last. In the LTF-001 study, participants will be seen approximately once a year for a total of 15 years from the time of receiving gene-editing therapy. Participants will be monitored for changes in health at each follow-up visit and blood will be taken at specific follow-up visits.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0347
Date of REC Opinion
27 Dec 2023
REC opinion
Further Information Favourable Opinion