DILIN - Prospective Study

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. 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 word
    v30
  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. 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 sites
    v22
  7. Notable Primary and study completion dates: Jul 2018 to Jul 2022
    • Site contacts updated at 2 of 6 sites
    v21
  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
  11. Minor Site contacts updated at 1 of 6 sites
    • Study description expanded, about 5 words
    v17
  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
    • Study completion date: Aug 2013 to Jul 2018
    • Site contacts updated at 1 of 8 sites
    v13
  16. Minor Study sites revised (8)v12
  17. 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. Re-verified, no change to tracked fieldsv7
  20. Notable Enrollment target: 450 to 900v6 Show 5 more changesShow less
    • Study sites: 5 to 8
    • Primary completion date: Aug 2013
    • Study completion date: Aug 2008 to Aug 2013
    • Publications: 11 to 13
    • Eligibility criteria expanded, about 1 word
  21. Minor Enrollment target: 450
    • Site contacts updated at 2 of 5 sites
    v5
  22. Minor Study completion date: May 2008 to Aug 2008
    • Site contacts updated at 2 of 5 sites
    v4
  23. Minor Study description shortened, about 29 wordsv3
  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 11
    v2
  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.
457 trials monitored
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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
(from sponsor)
Liver Diseases
Related terms Liver Diseases
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov