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Long-term Follow-up Study of Patients Receiving Onasemnogene Abeparvovec-xioi

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Site details revised at 14 of 31 sites
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv30
  3. Primary and study completion dates: Dec 29, 2035 to Dec 31, 2035v29
  4. Re-verified, no change to tracked fieldsv28
  5. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 86 to confirmed 85
    • Study sites: 32 to 31
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. 2 versions Re-verified since Sep 27, 2022, no change to tracked fieldsv25-v26
  2. Phase: Phase 4 to Phase 3
    • Enrollment target: 308 to 86
    • Primary endpoints: 16 to 20
    • Eligibility criteria shortened, about 2 words
    v24
  3. Re-verified, no change to tracked fieldsv23
  4. Lead sponsor: Novartis Pharmaceuticals to Novartis Gene Therapiesv22
  5. Study sites: 33 to 32
    • Eligibility criteria expanded, about 3 words
    v21
  6. Re-verified, no change to tracked fieldsv20
  7. Lead sponsor: AveXis, Inc. to Novartis Pharmaceuticalsv19
  8. Study sites revised (33)v18
  9. Primary endpoints: 13 to 16
    • Study sites: 34 to 33
    • Eligibility criteria shortened, about 6 words
    • Study arms: 2 to 1
    v17
  10. Study sites revised (34)v16
  11. Study sites: 35 to 34v15
  12. Site details revised at 1 of 35 sitesv14
  13. Primary and study completion dates: Dec 31, 2034 to Dec 29, 2035v13
  14. Study sites revised (35)v12
  15. Study sites revised (35)v11
  16. Re-verified, no change to tracked fieldsv10
  17. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 37 to 35
    v9
  18. Start date changed from estimate of Feb 13, 2020 to Feb 10, 2020v8
  19. Start date: Dec 31, 2019 to Feb 13, 2020
    • Study sites revised (37)
    v7
  20. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 4, 2019 to Dec 31, 2019
    • Site details revised at 37 of 37 sites
    v6
  21. Start date: Oct 1, 2019 to Nov 4, 2019v5
  22. Start date: Sep 1, 2019 to Oct 1, 2019v4
  23. Re-verified, no change to tracked fieldsv3
  24. Interventions: AVXS-101 (Biological) to Onasemnogene Abeparvovec-xioi (Biological)
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 1 word
    v2
  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 follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.
Trial Details
NCT Number NCT04042025
Lead Sponsor Novartis Gene Therapies
Conditions
(from sponsor)		 Spinal Muscular Atrophy Type I, Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy Type III, SMA
Related terms Spinal Muscular Atrophies of Childhood
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov