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Longitudinal Study of Urea Cycle Disorders

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 13, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Feb 2024); last known: Recruiting
  2. Primary completion date: Jul 2024 to Jul 2025 Trial status: Recruiting to Unknown · Enrollment target: 1009 to 1500 · Study sites: 16 to 15 · 3 morev40 Show all 7 changesShow less
    • Trial status: Recruiting to Unknown
    • Enrollment target: 1009 to 1500
    • Study sites: 16 to 15
    • Completion date: Dec 2024 to Jul 2026
    • Study description revised
    • Publications: 29 to 39

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  3. Enrollment target: 1100 to 1009 Study description revised · Site contacts updated at 4 of 16 sites · Publications: 26 to 29v39 Show all 4 changesShow less
    • Study description revised
    • Site contacts updated at 4 of 16 sites
    • Publications: 26 to 29

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  4. Primary completion date: Jul 2019 to Jul 2024 Completion date: Dec 2019 to Dec 2024 · Site contacts updated at 13 of 16 sites · Publications: 19 to 26v38 Show all 4 changesShow less
    • Completion date: Dec 2019 to Dec 2024
    • Site contacts updated at 13 of 16 sites
    • Publications: 19 to 26

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  5. Re-verified, no change to tracked fieldsv37
Show 35 earlier versionsHide 35 earlier versions
  1. Lead sponsor: Mendel Tuchman to Andrea Gropman Study sites: 14 to 16v36 Show all 2 changesShow less
    • Study sites: 14 to 16
  2. Publications: 13 to 19v35 Show moreShow less

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  3. Eligibility criteria expanded, about 135 words Study description shortened, about 33 words · Site contacts updated at 2 of 14 sites · Publications: 11 to 13v34 Show all 4 changesShow less
    • Study description shortened, about 33 words
    • Site contacts updated at 2 of 14 sites
    • Publications: 11 to 13

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  4. Study sites revised (14)v33 Show moreShow less

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  5. Lead sponsor: Children's National Research Institute to Mendel Tuchman Primary completion date: Jul 2014 to Jul 2019 · Completion date: Jul 2014 to Dec 2019v32 Show all 3 changesShow less
    • Primary completion date: Jul 2014 to Jul 2019
    • Completion date: Jul 2014 to Dec 2019
  6. Enrollment target: 550 to 1100 Publications: 8 to 11v31 Show all 2 changesShow less
    • Publications: 8 to 11

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  7. Lead sponsor: Office of Rare Diseases (ORD) to Children's National Research Institute Primary completion date: Sep 2009 to Jul 2014 · Enrollment target: 440 to 550 · Study sites: 15 to 14 · 4 morev30 Show all 8 changesShow less
    • Primary completion date: Sep 2009 to Jul 2014
    • Enrollment target: 440 to 550
    • Study sites: 15 to 14
    • Completion date: Sep 2010 to Jul 2014
    • Study description revised
    • Collaborators: 1 to 3
    • Publications: 4 to 8

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  8. Study sites: 14 to 15v29
  9. Study sites revised (14)v28 Show moreShow less

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  10. Study sites: 13 to 14v27
  11. Study description shortened, about 31 words Site contacts updated at 10 of 13 sites · Publications: 5 to 4v26 Show all 3 changesShow less
    • Site contacts updated at 10 of 13 sites
    • Publications: 5 to 4

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  12. Study sites: 12 to 13v25
  13. Study sites: 11 to 12v24
  14. Study sites: 10 to 11v23
  15. Study sites: 9 to 10v22
  16. Primary completion date: Sep 2009 Completion date: Sep 2010v21 Show all 2 changesShow less
    • Completion date: Sep 2010
  17. Study sites: 8 to 9v20
  18. Site details revised at 5 of 8 sitesv19
  19. Enrollment target: 1500 to 440 Study title revisedv18 Show all 2 changesShow less
    • Study title revised

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  20. Site details revised at 1 of 8 sitesv17
  21. Site details revised at 2 of 8 sitesv16
  22. Collaborators expanded, about 5 wordsv15 Show moreShow less

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  23. Site details revised at 1 of 8 sitesv14
  24. 2 versions Re-verified since May 22, 2006, no change to tracked fieldsv12-v13
  25. Site details revised at 6 of 8 sitesv11
  26. Site contacts updated at 6 of 8 sitesv10
  27. Eligibility criteria shortened, about 11 words Study description expanded, about 34 wordsv9 Show all 2 changesShow less
    • Study description expanded, about 34 words

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  28. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 2006 to Feb 2006 · Site details revised at 8 of 8 sitesv8 Show all 3 changesShow less
    • Start date: Mar 2006 to Feb 2006
    • Site details revised at 8 of 8 sites
  29. Start date: Jan 2006 to Mar 2006v7
  30. Start date: Dec 2005 to Jan 2006v6
  31. Eligibility criteria revisedv5 Show moreShow less

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  32. Re-verified, no change to tracked fieldsv4
  33. Start date: Nov 2005 to Dec 2005v3
  34. Start date: Oct 2005 to Nov 2005v2
  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.
Urea cycle disorders (UCD) are a group of rare inherited metabolism disorders. Infants and children with UCD commonly experience episodes of vomiting, lethargy, and coma. The purpose of this study is to perform a long-term analysis of a large group of individuals with various UCDs. The study will focus on the natural history, disease progression, treatment, and outcome of individuals with UCD.
Trial Details
NCT Number NCT00237315
Lead Sponsor Andrea Gropman
Collaborators: National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rare Diseases Clinical Research Network
Conditions Brain Diseases, Metabolic, Inborn, Amino Acid Metabolism, Inborn Errors, Urea Cycle Disorders
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov