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Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC Deficiency

Study acronym: CAPtivate
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 9 sitesv44
  2. 2 versions Re-verified since Nov 13, 2025, no change to tracked fieldsv42-v43
  3. Study sites revised (9)v41 See this version in full on ClinicalTrials.gov ↗
  4. 5 versions Re-verified since Apr 24, 2024, no change to tracked fieldsv36-v40
  5. Primary and study completion dates: Dec 2027 to Dec 2029 Secondary endpoints: details revised at 2 of 2 entriesv35 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 2 entries
Show 33 earlier versionsHide 33 earlier versions
  1. 6 versions Re-verified since Jun 9, 2022, no change to tracked fieldsv29-v34
  2. Primary and study completion dates: Dec 2025 to Dec 2027 Trial status: Enrolling by Invitation to Active, Not Recruiting · Enrollment target: estimated 18 to confirmed 11 · Secondary endpoints: details revised at 2 of 2 entriesv28 Show 3 more changesShow less
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 11
    • Secondary endpoints: details revised at 2 of 2 entries
  3. Study sites: 8 to 9v27
  4. Study sites: 7 to 8v26
  5. Re-verified, no change to tracked fieldsv25
  6. Primary and study completion dates: Jan 2026 to Dec 2025v24
  7. Study sites: 6 to 7 Primary and study completion dates: Dec 2025 to Jan 2026v23 Show 1 more changeShow less
    • Primary and study completion dates: Dec 2025 to Jan 2026
  8. Re-verified, no change to tracked fieldsv22
  9. Enrollment target: 12 to 18 Primary and study completion dates: Dec 2024 to Dec 2025 · Eligibility criteria revisedv21 Show 2 more changesShow less
    • Primary and study completion dates: Dec 2024 to Dec 2025
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  10. Secondary endpoints: details revised at 1 of 2 entriesv20
  11. Re-verified, no change to tracked fieldsv19
  12. Study sites: 5 to 6v18
  13. 7 versions Re-verified since May 1, 2019, no change to tracked fieldsv11-v17
  14. Study sites: 3 to 5v10
  15. 3 versions Re-verified since Jan 11, 2019, no change to tracked fieldsv7-v9
  16. Primary and study completion dates: Dec 2023 to Dec 2024v6
  17. Study sites: 2 to 3v5
  18. Study sites: 1 to 2v4
  19. Re-verified, no change to tracked fieldsv3
  20. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Sep 2018 to Aug 30, 2018v2 Show 1 more changeShow less
    • Start date changed from estimate of Sep 2018 to Aug 30, 2018
  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.
Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.
Trial Details
NCT Number NCT03636438
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Ornithine Transcarbamylase (OTC) Deficiency
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov