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

Study Identifier:
COAV101A12308
ClinicalTrials.gov Identifier:
NCT05335876
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Novartis Pharmaceuticals
Recruiting

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
  • Biological: onasemnogene abeparvovec
Date
Dec 2022 - Sep 2030
Phase 1
Phase 2
Phase 3
Phase 4
Patient Requirements
Sex: Female & Male
Age: 0 - 100 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • There are no exclusion criteria for this study.

Protocol 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.

Trial Locations

Location
Status
Location
Child Hosp Of The Kings Daughters
Norfolk, Virginia, United States, 23507
Status
Recruiting
Location
Novartis Investigative Site
Sydney, New South Wales, Australia, 2031
Status
Recruiting
Location
Novartis Investigative Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Novartis Investigative Site
Curitiba, Paraná, Brazil, 81520-060
Status
Recruiting
Location
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05403 000
Status
Recruiting
Location
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
Status
Recruiting
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