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Phase I/II/III Gene Transfer Clinical Trial of scAAV9.U1a.hSGSH

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 12 words Site details revised at 4 of 5 sites · Publications: details revised at 3 of 3 entries Show 2 more changesShow less
    • Site details revised at 4 of 5 sites
    • Publications: details revised at 3 of 3 entries
  2. Re-verified, no change to tracked fieldsv44
  3. Site details revised at 1 of 5 sitesv43
  4. Primary and study completion pushed from Jul 2027 to Mar 2029v42
  5. Site details revised at 1 of 5 sitesv41
Show 39 earlier versionsHide 39 earlier versions
  1. Eligibility criteria shortened, about 17 wordsv40 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv39
  3. Eligibility criteria expanded, about 101 words Site details revised at 2 of 5 sitesv38 Show 1 more changeShow less
    • Site details revised at 2 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv37
  5. Site details revised at 1 of 5 sitesv36
  6. Start date: Mar 2016 to Apr 25, 2016 Eligibility criteria expanded, about 29 words · Site contacts updated at 2 of 5 sitesv35 Show 2 more changesShow less
    • Eligibility criteria expanded, about 29 words
    • Site contacts updated at 2 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  7. Study description shortened, about 8 words Site contacts updated at 1 of 5 sitesv34 Show 1 more changeShow less
    • Site contacts updated at 1 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  8. Trial status: Active, Not Recruiting to Recruiting Eligibility criteria expanded, about 17 words · Secondary endpoints revised (7) · Site details revised at 5 of 5 sitesv33 Show 3 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (7)
    • Site details revised at 5 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  9. Primary and study completion dates: Jan 2025 to Jul 2027 Primary endpoint revised · Enrollment target: 28 to 36 · Interventions: ABO-102 (Biological), Adjuvant Immunosuppression (IS) Therapy (Drug) to Adjuvant IM Therapy (Drug), Optimized Prophylactic IM Therapy (Drug), Prophylactic Immunomodulatory (IM) Therapy (Drug), UX111 (Biological) · 4 morev32 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 28 to 36
    • Interventions: ABO-102 (Biological), Adjuvant Immunosuppression (IS) Therapy (Drug) to Adjuvant IM Therapy (Drug), Optimized Prophylactic IM Therapy (Drug), Prophylactic Immunomodulatory (IM) Therapy (Drug), UX111 (Biological)
    • Eligibility criteria expanded, about 451 words
    • Secondary endpoints: 8 to 7
    • Study description revised
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  10. Primary and study completion dates: Jun 2024 to Jan 2025v31
  11. 4 versions Re-verified since Aug 2, 2023, no change to tracked fieldsv27-v30
  12. Phase: Phase 1/2 to Phase 2/3 Primary endpoints: 2 to 1 · Primary and study completion dates: Dec 2024 to Jun 2024 · Interventions: ABO-102 (Biological) to ABO-102 (Biological), Adjuvant Immunosuppression (IS) Therapy (Drug) · 3 morev26 Show 6 more changesShow less
    • Primary endpoints: 2 to 1
    • Primary and study completion dates: Dec 2024 to Jun 2024
    • Interventions: ABO-102 (Biological) to ABO-102 (Biological), Adjuvant Immunosuppression (IS) Therapy (Drug)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 13 to 8
    • Study description expanded, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  13. Re-verified, no change to tracked fieldsv25
  14. Lead sponsor: Abeona Therapeutics, Inc to Ultragenyx Pharmaceutical Inc Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 22 to confirmed 28 · Study description expanded, about 17 words · 3 morev24 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 22 to confirmed 28
    • Study description expanded, about 17 words
    • Site details revised at 5 of 5 sites
    • Study title revised
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  15. Site contacts updated at 1 of 5 sitesv23
  16. Primary and study completion dates: Dec 2022 to Dec 2024 Study sites: 4 to 5v22 Show 1 more changeShow less
    • Study sites: 4 to 5
  17. Eligibility criteria revisedv21 See this version in full on ClinicalTrials.gov ↗
  18. Re-verified, no change to tracked fieldsv20
  19. Study sites: 6 to 4v19
  20. Site details revised at 1 of 6 sitesv18
  21. Publications: 1 to 3v17 See this version in full on ClinicalTrials.gov ↗
  22. Study sites: 4 to 6 Eligibility criteria shortened, about 15 words · Study description shortened, about 25 words · Publications: 2 to 1v16 Show 3 more changesShow less
    • Eligibility criteria shortened, about 15 words
    • Study description shortened, about 25 words
    • Publications: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 3 to 4v15
  24. Site contacts updated at 1 of 3 sitesv14
  25. Interventions: scAAV9.U1a.hSGSH (Biological) to ABO-102 (Biological) Site contacts updated at 3 of 3 sitesv13 Show 1 more changeShow less
    • Site contacts updated at 3 of 3 sites
  26. Primary completion date: Dec 2019 to Dec 2022 Completion date: Dec 2021 to Dec 2022 · Eligibility criteria shortened, about 122 words · Secondary endpoints: details revised at 2 of 13 entries · 1 morev12 Show 4 more changesShow less
    • Completion date: Dec 2021 to Dec 2022
    • Eligibility criteria shortened, about 122 words
    • Secondary endpoints: details revised at 2 of 13 entries
    • Site contacts updated at 2 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  27. Primary endpoints: 1 to 2 Enrollment target: 16 to 22 · Completion date: Dec 2020 to Dec 2021 · Eligibility criteria expanded, about 45 words · 2 morev11 Show 5 more changesShow less
    • Enrollment target: 16 to 22
    • Completion date: Dec 2020 to Dec 2021
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: 7 to 13
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  28. Site contacts updated at 2 of 3 sitesv10
  29. Secondary endpoints revised (7) Site contacts updated at 1 of 3 sites · Eligibility criteria shortened, about 2 wordsv9 Show 2 more changesShow less
    • Site contacts updated at 1 of 3 sites
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  30. Eligibility criteria revised Secondary endpoints revised (7)v8 Show 1 more changeShow less
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  31. Site contacts updated at 1 of 3 sitesv7
  32. Enrollment target: 9 to 16 Study sites: 1 to 3 · Eligibility criteria expanded, about 51 words · Secondary endpoints: 5 to 7 · 2 morev6 Show 5 more changesShow less
    • Study sites: 1 to 3
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints: 5 to 7
    • Study arms: 2 to 3
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  33. Lead sponsor: Kevin Flanigan to Abeona Therapeutics, Inc Collaborators shortened, about 3 words · Study title shortened, about 4 wordsv5 Show 2 more changesShow less
    • Collaborators shortened, about 3 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  34. Interventions: scAAV9.U1a.hSGSH (Genetic) to scAAV9.U1a.hSGSH (Biological)v4
  35. Re-verified, no change to tracked fieldsv3
  36. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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.
The main objective of this study is to evaluate the efficacy and safety of UX111 for the treatment of MPS IIIA.
Trial Details
NCT Number NCT02716246
Lead Sponsor Ultragenyx Pharmaceutical Inc
Collaborators: Abeona Therapeutics, Inc
Conditions MPS IIIA, Sanfilippo Syndrome, Sanfilippo A, Mucopolysaccharidosis III
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov