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A Study to Determine the Effect of Triheptanoin Compared With Even-Chain MCT on MCEs in Pediatric Patients With LC-FAOD

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

Record History

  1. Eligibility criteria expanded, about 27 words Secondary endpoints: details revised at 1 of 19 entries · Site details revised at 1 of 15 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 19 entries
    • Site details revised at 1 of 15 sites
  2. 3 versions Re-verified since Jan 9, 2026, no change to tracked fieldsv24-v26
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 60 to confirmed 69 · Site details revised at 15 of 15 sitesv23 Show 2 more changesShow less
    • Enrollment target: estimated 60 to confirmed 69
    • Site details revised at 15 of 15 sites
  4. Study sites: 16 to 15v22
  5. Trial status: Active, Not Recruiting to Recruiting Site details revised at 16 of 16 sitesv21 Show 1 more changeShow less
    • Site details revised at 16 of 16 sites
Show 19 earlier versionsHide 19 earlier versions
  1. Primary and study completion dates: Sep 2026 to Aug 2027 Primary endpoint revised · Eligibility criteria expanded, about 27 words · Secondary endpoints: 22 to 19 · 3 morev20 Show 6 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 22 to 19
    • Study sites revised (16)
    • Study title revised
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 14 to 16v19 Show 1 more changeShow less
    • Study sites: 14 to 16
  3. Re-verified, no change to tracked fieldsv18
  4. Study sites: 15 to 14v17
  5. 6 versions Re-verified since Jan 22, 2024, no change to tracked fieldsv11-v16
  6. Study sites: 13 to 15v10
  7. Site details revised at 1 of 13 sitesv9
  8. Site details revised at 1 of 13 sitesv8
  9. Site details revised at 1 of 13 sitesv7
  10. Site details revised at 1 of 13 sitesv6
  11. Eligibility criteria expanded, about 13 words Secondary endpoints revised (22) · Site details revised at 3 of 13 sitesv5 Show 2 more changesShow less
    • Secondary endpoints revised (22)
    • Site details revised at 3 of 13 sites

    See this version in full on ClinicalTrials.gov ↗

  12. Site contacts updated at 12 of 13 sitesv4
  13. Site contacts updated at 13 of 13 sitesv3
  14. 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 main goal of this study is to evaluate the effects of triheptanoin versus Medium-chain Triglycerides (MCT) on frequency of Major Clinical Events (MCEs).
Trial Details
NCT Number NCT05933200
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov