ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03306277

Public ClinicalTrials.gov record NCT03306277. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 11:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT03306277
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Gene Therapies
Industry
Enrollment
22 participants

Conditions and interventions

Interventions

  • Onasemnogene Abeparvovec-xioi Biological

Biological

Eligibility (public fields only)

Age range
Up to 180 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 23, 2017
Primary completion
Nov 11, 2019
Completion
Nov 11, 2019
Last update posted
Jan 25, 2026

2017 – 2019

United States locations

U.S. sites
16
U.S. states
15
U.S. cities
16
Facility City State ZIP Site status
David Geffen School of Medicine at UCLA Los Angeles California 90095
Stanford University Stanford California 94305
Children's Hospital Colorado Aurora Colorado 80045
Nemours Children's Hospital Orlando Florida 32827
Ann and Robert H Lurie Children's Hospital Chicago Illinois 60611
Johns Hopkins Pediatric Neurology Baltimore Maryland 21287
Boston Children's Hospital Boston Massachusetts 02115
Washington Unviersity School of Medicine St Louis Missouri 63110
Columbia University New York New York 10032
Duke University Durham North Carolina 27713
Nationwide Children's Hospital Columbus Ohio 43205
Oregon Health and Science University Portland Oregon 97239
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
University of Texas Southwestern Medical Center Dallas Texas 75235
University of Utah Salt Lake City Utah 84112
University of Wisconsin (Madison) Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03306277, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 25, 2026 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03306277 live on ClinicalTrials.gov.

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