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

Running, not enrolling · Phase 3

Conditions studied: Spinal Muscular Atrophy (SMA)

In brief

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.

Key facts

Study ID

NCT05335876

Run by

Novartis Pharmaceuticals

People needed

20

Starts

2022-12-19

Expected to finish

2031-04-30

Last updated by the study team

2026-07-09

Who can join

Age: any, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participated in an OAV101 clinical trial.
• Written informed consent must be obtained before any assessment is performed.
• Patient/Parent/legal guardian willing and able to comply with study procedures.

You may not qualify if…

• There are no exclusion criteria for this study.

Where it is running

• Child Hosp Of The Kings Daughters — Norfolk, Virginia, United States
• Novartis Investigative Site — Sydney, New South Wales, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Curitiba, Paraná, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Chongqing, Chongqing Municipality, China
• Novartis Investigative Site — Guangzhou, Guangdong, China
• Novartis Investigative Site — Chengdu, Sichuan, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Copenhagen, Denmark
• Novartis Investigative Site — Bron, France
• Novartis Investigative Site — Garches, France
• Novartis Investigative Site — Strasbourg, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Kurume, Fukuoka, Japan
• Novartis Investigative Site — Shinjuku Ku, Tokyo, Japan
• Novartis Investigative Site — Kuala Lumpur, Malaysia
• Novartis Investigative Site — Kuala Lumpur, Malaysia
• Novartis Investigative Site — Utrecht, Netherlands
• Novartis Investigative Site — Riyadh, Saudi Arabia
• Novartis Investigative Site — Singapore, Singapore

Full record on ClinicalTrials.gov

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