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Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 60 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Mar 4, 2026, no change to tracked fieldsv59-v60
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 16 of 16 sitesv58 Show 1 more changeShow less
    • Site details revised at 16 of 16 sites
  3. Re-verified, no change to tracked fieldsv57
  4. Site details revised at 1 of 16 sitesv56
  5. 3 versions Re-verified since Apr 29, 2025, no change to tracked fieldsv53-v55
Show 42 earlier versionsHide 42 earlier versions
  1. Site details revised at 1 of 16 sitesv52
  2. 2 versions Re-verified since Jan 6, 2025, no change to tracked fieldsv50-v51
  3. Site details revised at 1 of 16 sitesv49
  4. Re-verified, no change to tracked fieldsv48
  5. Site details revised at 1 of 16 sitesv47
  6. Site details revised at 1 of 16 sitesv46
  7. Primary endpoints revised (5) Enrollment target: 200 to 150 · Eligibility criteria shortened, about 18 words · Secondary endpoints: 17 to 24 · 2 morev45 Show 5 more changesShow less
    • Enrollment target: 200 to 150
    • Eligibility criteria shortened, about 18 words
    • Secondary endpoints: 17 to 24
    • Study description expanded, about 27 words
    • Study arms: 5 to 3

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv44
  9. Study sites: 15 to 16v43
  10. Re-verified, no change to tracked fieldsv42
  11. Site details revised at 1 of 15 sitesv41
  12. Re-verified, no change to tracked fieldsv40
  13. Study sites: 9 to 15v39
  14. 3 versions Re-verified since Nov 8, 2023, no change to tracked fieldsv36-v38
  15. Study sites: 8 to 9v35
  16. 2 versions Re-verified since Aug 18, 2023, no change to tracked fieldsv33-v34
  17. Study sites: 7 to 8 Secondary endpoints revised (17)v32 Show 1 more changeShow less
    • Secondary endpoints revised (17)

    See this version in full on ClinicalTrials.gov ↗

  18. Enrollment target: 300 to 200 Primary and study completion dates: Mar 2031 to Dec 2035 · Eligibility criteria shortened, about 55 words · Secondary endpoints: 15 to 17 · 1 morev31 Show 4 more changesShow less
    • Primary and study completion dates: Mar 2031 to Dec 2035
    • Eligibility criteria shortened, about 55 words
    • Secondary endpoints: 15 to 17
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  19. 2 versions Re-verified since Apr 24, 2023, no change to tracked fieldsv29-v30
  20. Site details revised at 1 of 7 sitesv28
  21. 4 versions Re-verified since Dec 16, 2022, no change to tracked fieldsv24-v27
  22. Site details revised at 1 of 7 sitesv23
  23. Study sites: 6 to 7v22
  24. 3 versions Re-verified since Aug 29, 2022, no change to tracked fieldsv19-v21
  25. Site details revised at 1 of 6 sitesv18
  26. Re-verified, no change to tracked fieldsv17
  27. Study sites: 3 to 6v16
  28. 3 versions Re-verified since Feb 11, 2022, no change to tracked fieldsv13-v15
  29. Study Status, Referencesv12
  30. Start date changed from estimate of Nov 2021 to Nov 30, 2021v11
  • 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 of this study is to assess the long-term safety, including pregnancy, infant, and lactation outcomes, of patients with LC-FAOD who are enrolled in the DMP.
Trial Details
NCT Number NCT04632953
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov