Longitudinal Study of Urea Cycle Disorders

StatusUnknown
PhaseNot specified
Started

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.

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Record History

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  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 2025v40 Show 6 more changesShow less
    • Trial status: Recruiting to Unknown
    • Enrollment target: 1009 to 1500
    • Study sites: 16 to 15
    • Study completion date: Dec 2024 to Jul 2026
    • Study description revised
    • Publications: 29 to 39
  3. Enrollment target: 1100 to 1009
    • Study description revised
    • Site contacts updated at 4 of 16 sites
    • Publications: 26 to 29
    v39
  4. Primary completion date: Jul 2019 to Jul 2024
    • Study completion date: Dec 2019 to Dec 2024
    • Site contacts updated at 13 of 16 sites
    • Publications: 19 to 26
    v38
  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 16
    v36
  2. Publications: 13 to 19v35
  3. Eligibility criteria expanded, about 135 words
    • Study description shortened, about 33 words
    • Site contacts updated at 2 of 14 sites
    • Publications: 11 to 13
    v34
  4. Study sites revised (14)v33
  5. Lead sponsor: Children's National Research Institute to Mendel Tuchman
    • Primary completion date: Jul 2014 to Jul 2019
    • Study completion date: Jul 2014 to Dec 2019
    v32
  6. Enrollment target: 550 to 1100
    • Publications: 8 to 11
    v31
  7. Lead sponsor: Office of Rare Diseases (ORD) to Children's National Research Institutev30 Show 7 more changesShow less
    • Primary completion date: Sep 2009 to Jul 2014
    • Enrollment target: 440 to 550
    • Study sites: 15 to 14
    • Study completion date: Sep 2010 to Jul 2014
    • Study description revised
    • Collaborators: 1 to 3
    • Publications: 4 to 8
  8. Study sites: 14 to 15v29
  9. Study sites revised (14)v28
  10. Study sites: 13 to 14v27
  11. Study description shortened, about 31 words
    • Site contacts updated at 10 of 13 sites
    • Publications: 5 to 4
    v26
  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
    • Study completion date: Sep 2010
    v21
  17. Study sites: 8 to 9v20
  18. Site details revised at 5 of 8 sitesv19
  19. Enrollment target: 1500 to 440
    • Study title revised
    v18
  20. Site details revised at 1 of 8 sitesv17
  21. Site details revised at 2 of 8 sitesv16
  22. Collaborators expanded, about 5 wordsv15
  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 words
    v9
  28. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2006 to Feb 2006
    • Site details revised at 8 of 8 sites
    v8
  29. Start date: Jan 2006 to Mar 2006v7
  30. Start date: Dec 2005 to Jan 2006v6
  31. Eligibility criteria revisedv5
  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
  • 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
(from sponsor)		 Brain Diseases, Metabolic, Inborn, Amino Acid Metabolism, Inborn Errors, Urea Cycle Disorders
Related terms Amino Acid Metabolism, Inborn Errors, Brain Diseases, Metabolic, Inborn, Urea Cycle Disorders, Inborn
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov