Drug-Induced Liver Injury (DILI) Network Retrospective

Study acronym: ILIAD
StatusRecruiting
PhaseNot specified
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv33
  2. Study sites: 7 to 6v32
  3. Site contacts updated at 4 of 7 sites
    • Study title expanded, about 1 word
    v31
  4. Study sites revised (7)v30
  5. Primary and study completion dates: Jun 2028 to Jul 31, 2028v29
Show 27 earlier versionsHide 27 earlier versions
  1. Primary and study completion dates: Jun 2023 to Jun 2028v28
  2. Enrollment target: 200 to 400v27
  3. Site contacts updated at 2 of 7 sitesv26
  4. Site contacts updated at 4 of 7 sitesv25
  5. Re-verified, no change to tracked fieldsv24
  6. Site contacts updated at 2 of 7 sitesv23
  7. Primary and study completion dates: Jun 2022 to Jun 2023
    • Site contacts updated at 3 of 7 sites
    v22
  8. Primary and study completion dates: Jun 2018 to Jun 2022
    • Site contacts updated at 1 of 7 sites
    v21
  9. Primary completion date: Jun 2017 to Jun 2018v20
  10. Study sites: 6 to 7v19
  11. Re-verified, no change to tracked fieldsv18
  12. Site contacts updated at 1 of 6 sitesv17
  13. Re-verified, no change to tracked fieldsv16
  14. Eligibility criteria shortened, about 45 words
    • Study description shortened, about 32 words
    v15
  15. Study sites: 8 to 6
    • Study completion date: Jun 2017 to Jun 2018
    v14
  16. Re-verified, no change to tracked fieldsv13
  17. Site details revised at 3 of 8 sitesv12
  18. Primary and study completion dates: Aug 2013 to Jun 2017
    • Study sites revised (8)
    v11
  19. Re-verified, no change to tracked fieldsv10
  20. Site contacts updated at 3 of 8 sitesv9
  21. Enrollment target: 100 to 200v8 Show 4 more changesShow less
    • Study sites: 4 to 8
    • Eligibility criteria expanded, about 23 words
    • Publications: 1 to 2
    • Study description expanded, about 5 words
  22. Enrollment target: 200 to 100v7 Show 4 more changesShow less
    • Study sites: 5 to 4
    • Primary completion date: Aug 2013
    • Study completion date: Aug 2008 to Aug 2013
    • Study title revised
  23. Site contacts updated at 2 of 5 sitesv6
  24. Re-verified, no change to tracked fieldsv5
  25. Study completion date: May 2008 to Aug 2008
    • Site contacts updated at 2 of 5 sites
    v4
  26. Eligibility criteria shortened, about 6 wordsv3
  27. Study title shortened, about 1 wordv2
  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.
Duke University
457 trials monitored
See 58 trials at risk
The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI and the relevant clinical data concerning the episode of DILI; and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as living immune cells for phenotyping studies. A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be recontacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI.
Trial Details
NCT Number NCT00360646
Lead Sponsor Duke University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Drug Induced Liver Injury
Related terms Chemical and Drug Induced Liver Injury
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov