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ACTIVE NOT RECRUITING
NCT03421977

Long-Term Follow-up Study for Patients From AVXS-101-CL-101

Sponsor: Novartis Gene Therapies

View on ClinicalTrials.gov

Summary

This is a long term, safety follow up study of patients in the AVXS-101-CL-101 gene replacement therapy clinical trial for SMA Type 1 delivering onasemnogene abeparvovec-xioi. Patients will roll over from the parent study into this long-term study for continuous safety monitoring for up to 15 years.

Official title: A Long Term Follow up Safety Study of Patients in the AVXS-101-CL-101 Gene Replacement Therapy Clinical Trial for Spinal Muscular Atrophy Type 1 Delivering AVXS 101

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

13

Start Date

2017-09-21

Completion Date

2030-12-02

Last Updated

2025-04-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

Onasemnogene Abeparvovec-xioi

Patients received treatment with onasemnogene abeparvovec-xioi in the parent study, AVXS-101-CL-101

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States