Health Trials

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

ConditionSpinal Muscular Atrophy (SMA)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-100
SponsorNovartis Pharmaceuticals

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • onasemnogene abeparvovec

Treatment groups

175 Participants
are divided into 1 treatment group

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov