Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04884815 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase 1/2/3 Study of UX701 Gene Therapy in Adults With Wilson Disease

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 57 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 17 words Site details revised at 2 of 16 sites Show 1 more changeShow less
    • Site details revised at 2 of 16 sites
  2. Study sites revised (16)v56 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv55
  4. Study sites: 17 to 16v54
  5. Trial status: Recruiting to Active, Not Recruiting Site details revised at 17 of 17 sitesv53 Show 1 more changeShow less
    • Site details revised at 17 of 17 sites
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 17 sitesv52
  2. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Aug 2026 to Mar 2029 · Primary endpoints: 12 to 13 · Enrollment target: 78 to 82 · 7 morev51 Show 10 more changesShow less
    • Primary completion date: Aug 2026 to Mar 2029
    • Primary endpoints: 12 to 13
    • Enrollment target: 78 to 82
    • Study sites: 16 to 17
    • Completion date: Nov 2031 to Mar 2034
    • Interventions: Placebo (Other), UX701 (Genetic) to Standard of Care (SOC) (Drug), UX701 (Genetic)
    • Eligibility criteria expanded, about 30 words
    • Study description shortened, about 38 words
    • Study arms: 5 to 6
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 17 to 16v50
  4. 3 versions Re-verified since Mar 27, 2024, no change to tracked fieldsv47-v49
  5. Primary completion date: Jan 2026 to Aug 2026 Completion date: Jan 2031 to Nov 2031v46 Show 1 more changeShow less
    • Completion date: Jan 2031 to Nov 2031
  6. Trial status: Recruiting to Active, Not Recruiting Site details revised at 17 of 17 sitesv45 Show 1 more changeShow less
    • Site details revised at 17 of 17 sites
  7. Site contacts updated at 1 of 17 sitesv44
  8. Re-verified, no change to tracked fieldsv43
  9. Site details revised at 1 of 17 sitesv42
  10. Site contacts updated at 1 of 17 sitesv41
  11. Site contacts updated at 1 of 17 sitesv40
  12. Site contacts updated at 1 of 17 sitesv39
  13. Study sites: 18 to 17v38
  14. Re-verified, no change to tracked fieldsv37
  15. Site details revised at 2 of 18 sitesv36
  16. Interventions: Placebo (Other), Placebo for oral corticosteroids (Drug), UX701 (Genetic), oral corticosteroids (Drug) to Placebo (Other), UX701 (Genetic) Eligibility criteria shortened, about 9 words · Secondary endpoints: 5 to 4 · Study description expanded, about 4 wordsv35 Show 3 more changesShow less
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 5 to 4
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  17. Site contacts updated at 1 of 18 sitesv34
  18. Site contacts updated at 2 of 18 sitesv33
  19. Study sites: 17 to 18v32
  20. Study sites: 18 to 17v31
  21. Study sites: 17 to 18v30
  22. Site contacts updated at 2 of 17 sitesv29
  23. Study sites: 16 to 17v28
  24. Study sites: 15 to 16v27
  25. Study sites: 14 to 15v26
  26. Study sites: 13 to 14v25
  27. Re-verified, no change to tracked fieldsv24
  28. Study sites: 12 to 13v23
  29. Re-verified, no change to tracked fieldsv22
  30. Study sites: 11 to 12v21
  31. Enrollment target: 90 to 78 Study sites: 12 to 11 · Study arms: 10 to 5v20 Show 2 more changesShow less
    • Study sites: 12 to 11
    • Study arms: 10 to 5
  32. 2 versions Re-verified since Aug 22, 2022, no change to tracked fieldsv18-v19
  33. Study sites: 11 to 12v17
  34. Study sites: 9 to 11v16
  35. Re-verified, no change to tracked fieldsv15
  36. Study sites: 7 to 9v14
  37. Study sites: 6 to 7v13
  38. 2 versions Re-verified since Feb 14, 2022, no change to tracked fieldsv11-v12
  39. Study sites: 5 to 6v10
  40. Re-verified, no change to tracked fieldsv9
  41. Study sites: 4 to 5v8
  • 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 objectives of this study are to evaluate the safety of single IV doses of UX701 in patients with Wilson disease, to select the UX701 dose with the best benefit/risk profile based on the totality of safety and efficacy data and to evaluate the effect of UX701 on copper regulation.
Trial Details
NCT Number NCT04884815
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Wilson Disease
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov