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DILIN - Prospective Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv32
  2. Minor Study sites: 7 to 6v31
  3. Minor Study sites: 6 to 7 Study title expanded, about 1 wordv30 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Primary and study completion dates: Jun 2028 to Jul 31, 2028v29
  5. Notable Primary and study completion dates: Jun 2023 to Jun 2028v28
Show 26 earlier versionsHide 26 earlier versions
  1. Notable Enrollment target: 1600 to 4000v27
  2. Minor Site contacts updated at 2 of 6 sitesv26
  3. Minor Site contacts updated at 4 of 6 sitesv25
  4. Minor Re-verified, no change to tracked fieldsv24
  5. Minor Site contacts updated at 2 of 6 sitesv23
  6. Notable Primary and study completion dates: Jul 2022 to Jun 2023 Site contacts updated at 3 of 6 sitesv22 Show 1 more changeShow less
    • Site contacts updated at 3 of 6 sites
  7. Notable Primary and study completion dates: Jul 2018 to Jul 2022 Site contacts updated at 2 of 6 sitesv21 Show 1 more changeShow less
    • Site contacts updated at 2 of 6 sites
  8. Notable Primary completion date: Jul 2017 to Jul 2018v20
  9. Minor Site contacts updated at 2 of 6 sitesv19
  10. Minor Study description expanded, about 3 wordsv18 See this version in full on ClinicalTrials.gov ↗
  11. Minor Site contacts updated at 1 of 6 sites Study description expanded, about 5 wordsv17 Show 1 more changeShow less
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  12. Notable Enrollment target: 900 to 1600v16
  13. Minor Site contacts updated at 2 of 6 sitesv15
  14. Minor Study sites: 8 to 6v14
  15. Notable Primary completion date: Aug 2013 to Jul 2017 Completion date: Aug 2013 to Jul 2018 · Site contacts updated at 1 of 8 sitesv13 Show 2 more changesShow less
    • Completion date: Aug 2013 to Jul 2018
    • Site contacts updated at 1 of 8 sites
  16. Minor Study sites revised (8)v12 See this version in full on ClinicalTrials.gov ↗
  17. Minor 3 versions Re-verified since Aug 7, 2012, no change to tracked fieldsv9-v11
  18. Minor Site details revised at 2 of 8 sitesv8
  19. Minor Re-verified, no change to tracked fieldsv7
  20. Notable Enrollment target: 450 to 900 Study sites: 5 to 8 · Primary completion date: Aug 2013 · Completion date: Aug 2008 to Aug 2013 · 2 morev6 Show 5 more changesShow less
    • Study sites: 5 to 8
    • Primary completion date: Aug 2013
    • Completion date: Aug 2008 to Aug 2013
    • Publications: 11 to 13
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  21. Minor Enrollment target: 450 Site contacts updated at 2 of 5 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 2 of 5 sites
  22. Minor Completion date: May 2008 to Aug 2008 Site contacts updated at 2 of 5 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 2 of 5 sites
  23. Minor Study description shortened, about 29 wordsv3 See this version in full on ClinicalTrials.gov ↗
  24. Minor Eligibility criteria shortened, about 85 words Study description shortened, about 23 words · Site contacts updated at 1 of 5 sites · Publications: 19 to 11v2 Show 3 more changesShow less
    • Study description shortened, about 23 words
    • Site contacts updated at 1 of 5 sites
    • Publications: 19 to 11

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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.
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The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.
Trial Details
NCT Number NCT00345930
Lead Sponsor Duke University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Liver Diseases
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov