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Clinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) Deficiency

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv41
  2. Enrollment increased: 32 → 37 participantsv40
  3. Primary completion date: Feb 19, 2025 to Sep 2027v39
  4. 2 versions Re-verified since Oct 7, 2025, no change to tracked fieldsv37-v38
  5. Study sites: 17 to 16v36
Show 34 earlier versionsHide 34 earlier versions
  1. Re-verified, no change to tracked fieldsv35
  2. Enrollment target: 50 to 32 Primary endpoints revised (2) · Study sites: 25 to 17 · Completion date: Dec 2028 to Mar 2031 · 3 morev34 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 25 to 17
    • Completion date: Dec 2028 to Mar 2031
    • Eligibility criteria revised
    • Secondary endpoints: 8 to 11
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Mar 2025 to Feb 19, 2025 · Site details revised at 25 of 25 sitesv33 Show 2 more changesShow less
    • Primary completion date changed from estimate of Mar 2025 to Feb 19, 2025
    • Site details revised at 25 of 25 sites
  4. Primary completion date: Dec 2024 to Mar 2025v32
  5. 2 versions Re-verified since Nov 19, 2024, no change to tracked fieldsv30-v31
  6. Site details revised at 1 of 25 sitesv29
  7. 2 versions Re-verified since Aug 16, 2024, no change to tracked fieldsv27-v28
  8. Site details revised at 2 of 25 sitesv26
  9. Study sites: 26 to 25v25
  10. Re-verified, no change to tracked fieldsv24
  11. Primary endpoints revised (2) Eligibility criteria shortened, about 12 words · Secondary endpoints: 9 to 8v23 Show 2 more changesShow less
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: 9 to 8

    See this version in full on ClinicalTrials.gov ↗

  12. Site details revised at 1 of 26 sitesv22
  13. 3 versions Re-verified since Oct 30, 2023, no change to tracked fieldsv19-v21
  14. Study sites: 23 to 26v18
  15. Site details revised at 1 of 23 sitesv17
  16. Site details revised at 2 of 23 sitesv16
  17. Site details revised at 4 of 23 sitesv15
  18. Site details revised at 1 of 23 sitesv14
  19. Site details revised at 1 of 23 sitesv13
  20. Site details revised at 1 of 23 sitesv12
  21. Site details revised at 2 of 23 sitesv11
  22. Site details revised at 2 of 23 sitesv10
  23. Start date changed from estimate of Dec 2022 to Oct 18, 2022v9
  24. Site details revised at 3 of 23 sitesv8
  25. Re-verified, no change to tracked fieldsv7
  26. Start date: Sep 2022 to Dec 2022v6
  27. Re-verified, no change to tracked fieldsv5
  28. Study sites: 20 to 23v4
  29. Start date: May 2022 to Sep 2022v3
  30. Re-verified, no change to tracked fieldsv2
  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 primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels.
Trial Details
NCT Number NCT05345171
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions OTC Deficiency
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov