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Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
Sponsor: Novartis Pharmaceuticals
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.
Official title: Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 IT or OAV101 IV in Clinical Trials
Key Details
Gender
All
Age Range
0 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2022-12-19
Completion Date
2031-02-27
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
onasemnogene abeparvovec
Onasemnogene abeparvovec is a non-replicating recombinant adeno-associated virus serotype 9 containing the human survival motor neuron gene under the control of the ytomegalovirus enhancer/chicken β-actin-hybrid promoter. Onasemnogene abeparvovec is administered as a one-time intravenous (IV) infusion or intrathecal (IT) injection. Dosage determined by participant weight.
Locations (32)
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
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom
Novartis Investigative Site
Hanoi, Vietnam