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NOT YET RECRUITING
NCT07633951
NA

Multicenter Epidemiological Study for the Evaluation of the Seroprevalence of Total and Neutralizing Antibodies Against Adenoassociated Virus Serotypes Used in Gene Therapy in Patients With Neuromuscular Diseases of Genetic Origin.

Sponsor: Genethon

View on ClinicalTrials.gov

Summary

This study aims to assess the overall seroprevalence of neutralizing antibodies against different AAVs potentially used in gene therapy in patients with genetic neuromuscular diseases.

Key Details

Gender

All

Age Range

6 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2026-07-31

Completion Date

2027-12-31

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Dosage of AAV neutralizing antibodies

In each clinical site, the principal investigator will propose to his patients with neuromuscular disease of genetic origin to take a blood sample (4 mL of blood) to determine their level of immunity to certain AAVs used in gene therapy. The collected samples will be prepared and aliquoted on site and then sent frozen to the GENETHON laboratory for analysis. Only one sample per patient will be analyzed. All samples will be analyzed in batches.

Locations (1)

GENETHON

Évry, Île-de-France Region, France