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Long-Term Follow-up Study for Patients From AVXS-101-CL-101

Study acronym: START
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Site details revised
    • Publications: details revised at 3 of 3 entries
    • Eligibility criteria expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv16
  3. Primary and study completion dates: Dec 2033 to Dec 2, 2030v15
  4. 2 versions Re-verified since Nov 18, 2022, no change to tracked fieldsv13-v14
  5. Study description expanded, about 69 wordsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Lead sponsor: Novartis Pharmaceuticals to Novartis Gene Therapiesv10
  3. Re-verified, no change to tracked fieldsv9
  4. Lead sponsor: AveXis, Inc. to Novartis Pharmaceuticalsv8
  5. Start date: Aug 15, 2017 to Sep 21, 2017v7
  6. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 13
    v6
  7. Interventions: AVXS-101 (Biological) to Onasemnogene Abeparvovec-xioi (Biological)
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word
    v5
  8. 3 versions Re-verified since Dec 13, 2018, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a long term, safety follow up study of patients in the AVXS-101-CL-101 gene replacement therapy clinical trial for SMA Type 1 delivering onasemnogene abeparvovec-xioi. Patients will roll over from the parent study into this long-term study for continuous safety monitoring for up to 15 years.
Trial Details
NCT Number NCT03421977
Lead Sponsor Novartis Gene Therapies
Conditions
(from sponsor)		 Spinal Muscular Atrophy 1
Related terms Spinal Muscular Atrophies of Childhood
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov