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

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Spinal Muscular Atrophy (SMA)

Interventions: onasemnogene abeparvovec

Countries: United States, Australia, Belgium, Brazil, Canada, China, Denmark, France

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.

Eligibility overview

Sex: ALL

Age: 0 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

There are no exclusion criteria for this study.

Locations (32)

Norfolk, Virginia, United States
Sydney, New South Wales, Australia
Leuven, Belgium
Curitiba, Paraná, Brazil
São Paulo, São Paulo, Brazil
Montreal, Quebec, Canada
Chongqing, Chongqing Municipality, China
Guangzhou, Guangdong, China
Chengdu, Sichuan, China
Beijing, China
Beijing, China
Beijing, China
Copenhagen, Denmark
Bron, France
Garches, France
Strasbourg, France
Toulouse, France
Roma, RM, Italy
Kurume, Fukuoka, Japan
Shinjuku Ku, Tokyo, Japan
Kuala Lumpur, Malaysia
Kuala Lumpur, Malaysia
Utrecht, Netherlands
Riyadh, Saudi Arabia
Singapore, Singapore
Barcelona, Spain
Kaohsiung City, Taiwan
Taipei, Taiwan
Bangkok, Thailand
London, United Kingdom
+ 2 more on CT.gov