Completed PHASE3 INTERVENTIONAL 1-arm NCT03306277

Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1 (STR1VE)

Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

Sponsor: Novartis Gene Therapies

Conditions Gene Therapy SMA - Spinal Muscular Atrophy

Interventions Onasemnogene Abeparvovec-xioi

Updated 21 times since 2017 Last updated: Jan 7, 2026 Started: Oct 24, 2017 Primary completion: Nov 12, 2019 Completion: Nov 12, 2019

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Gene Therapy and SMA - Spinal Muscular Atrophy, this trial is completed. The trial is conducted by Novartis Gene Therapies and has accumulated 21 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

21 versions recorded

Feb 2026 — Present [monthly]

Completed PHASE3
Sep 2025 — Feb 2026 [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Sep 2022 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 16 earlier versions

Sep 2021 — Sep 2022 [monthly]

Completed PHASE3
Jun 2021 — Sep 2021 [monthly]

Completed PHASE3
Jan 2021 — Jun 2021 [monthly]

Completed PHASE3
Aug 2020 — Jan 2021 [monthly]

Completed PHASE3
Dec 2019 — Aug 2020 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Sep 2019 — Dec 2019 [monthly]

Active Not Recruiting PHASE3
Aug 2019 — Sep 2019 [monthly]

Active Not Recruiting PHASE3
Jul 2019 — Aug 2019 [monthly]

Active Not Recruiting PHASE3
May 2019 — Jul 2019 [monthly]

Active Not Recruiting PHASE3
Feb 2019 — May 2019 [monthly]

Active Not Recruiting PHASE3
Nov 2018 — Feb 2019 [monthly]

Active Not Recruiting PHASE3
Jul 2018 — Nov 2018 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jun 2018 — Jul 2018 [monthly]

Recruiting PHASE3
Jan 2018 — Jun 2018 [monthly]

Recruiting PHASE3
Dec 2017 — Jan 2018 [monthly]

Recruiting PHASE3
Oct 2017 — Dec 2017 [monthly]

Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Gene Therapies

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Baltimore, United States , Boston, United States , Chicago, United States , Columbus, United States , Dallas, United States , Durham, United States , Los Angeles, United States , Madison, United States , New York, United States and 6 more locations