drugset / Trial / NCT05335876

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

NCT05335876 ↗

Phase 3 Active not recruiting 20 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.

Timeline

Start
2022-12-19
Primary completion
2031-04-29
Completion
2031-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject AVXS-101 Gene therapy (AAV / viral vector) — Intravenous