Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311708
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-08
Brief Title:
Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector AAV9 and the Progression of Disease in Patients with Plakophilin 2 PKP2-associated Arrhythmogenic Right Ventricular Cardiomyopathy ARVC
Sponsor:
Tenaya Therapeutics
Organization:
Tenaya Therapeutics
Study Overview
Official Title:
Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector AAV9 in Patients with Plakophilin 2 PKP2-associated Arrhythmogenic Right Ventricular Cardiomyopathy ARVC
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIDGE
Brief Summary:
This is a multicenter non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy
Detailed Description:
Patients will receive standard of care treatments and assessments under the care of their healthcare provider Biologic samples will be collected annually to measure cardiac and other related biomarkers Clinical and observational data will be collected prospectively for up to 5 years from the date of enrollment or until the patient withdraws consentassent undergoes heart transplantation or dies
If consent is provided there may be a one-time sample collection to evaluate genetics for research purposes Quality of Life QoL questionnaires will be used to assess a patients wellbeing and quality of life If not included as part of a patients standard of care diagnostic Holter or equivalent monitoring will be required annually No investigational product will be administered Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy
If consent is provided there may be a one-time sample collection to evaluate genetics for research purposes Quality of Life QoL questionnaires will be used to assess a patients wellbeing and quality of life If not included as part of a patients standard of care diagnostic Holter or equivalent monitoring will be required annually No investigational product will be administered Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None