Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 IT or OAV101 IV in Clinical Trials
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
United States
Virginia
Child Hosp Of The Kings Daughters
RECRUITING
Norfolk
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Randwick
Belgium
Novartis Investigative Site
RECRUITING
Leuven
Canada
Novartis Investigative Site
RECRUITING
Montreal
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Chengdu
Novartis Investigative Site
RECRUITING
Chongqing
Novartis Investigative Site
RECRUITING
Guangzhou
Denmark
Novartis Investigative Site
RECRUITING
Copenhagen
France
Novartis Investigative Site
RECRUITING
Bron
Novartis Investigative Site
RECRUITING
Garches
Novartis Investigative Site
RECRUITING
Strasbourg
Novartis Investigative Site
RECRUITING
Toulouse
Italy
Novartis Investigative Site
RECRUITING
Roma
Japan
Novartis Investigative Site
RECRUITING
Kurume
Novartis Investigative Site
RECRUITING
Shinjuku Ku
Malaysia
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Netherlands
Novartis Investigative Site
RECRUITING
Utrecht
Saudi Arabia
Novartis Investigative Site
RECRUITING
Riyadh
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
Taipei
Thailand
Novartis Investigative Site
RECRUITING
Bangkok
United Kingdom
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Newcastle Upon Tyne
Viet Nam
Novartis Investigative Site
RECRUITING
Hanoi
Contact Information
Primary
Novartis Pharmaceuticals
medinfo.gtx@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
medinfoemea.gtx@novartis.com
+41613241111
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2030-06-26
Participants
Target number of participants: 175
Treatments
Experimental: Intravenous (IV) & Intrathecal (IT) Onasemnogene Abeparvovec
Patients who received OAV101 IT or OAV101 IV in clinical trials (COAV101A12306, COAV101B12301 and COAV101B12302)
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals