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TReatment for ImmUne Mediated PathopHysiology

Study acronym: TRIUMPH
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 73% 163 → 44 participants
See other at-risk trials from National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Record History

  1. Enrollment reduced: 163 → 44 participants Primary completion date changed from estimate of Aug 2026 to Aug 3, 2026v28 Show 1 more changeShow less
    • Primary completion date changed from estimate of Aug 2026 to Aug 3, 2026
  2. Enrollment closed, study ongoing Trial sites reduced: 24 → 17 locationsv27 Show 1 more changeShow less
    • Trial sites reduced: 24 → 17 locations
  3. Site details revised at 1 of 24 sitesv26
  4. Re-verified, no change to tracked fieldsv25
  5. Primary completion date: Apr 1, 2027 to Aug 2026 Completion date: May 31, 2027 to Feb 2027 · Study description expanded, about 14 words · Site details revised at 1 of 24 sites · 1 morev24 Show 4 more changesShow less
    • Completion date: May 31, 2027 to Feb 2027
    • Study description expanded, about 14 words
    • Site details revised at 1 of 24 sites
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

Show 22 earlier versionsHide 22 earlier versions
  1. Eligibility criteria expanded, about 17 wordsv23 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 23 to 24v22
  3. Study sites: 22 to 23v21
  4. Study sites revised (22)v20 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Jan 31, 2026 to Apr 1, 2027 Completion date: Jan 31, 2027 to May 31, 2027 · Site contacts updated at 19 of 22 sitesv19 Show 2 more changesShow less
    • Completion date: Jan 31, 2027 to May 31, 2027
    • Site contacts updated at 19 of 22 sites
  6. Eligibility criteria expanded, about 12 words Site contacts updated at 19 of 22 sitesv18 Show 1 more changeShow less
    • Site contacts updated at 19 of 22 sites

    See this version in full on ClinicalTrials.gov ↗

  7. Study description expanded, about 41 wordsv17 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 21 to 22v16
  9. Primary completion date: Apr 30, 2025 to Jan 31, 2026 Completion date: Jan 31, 2026 to Jan 31, 2027v15 Show 1 more changeShow less
    • Completion date: Jan 31, 2026 to Jan 31, 2027
  10. Site contacts updated at 1 of 21 sitesv14
  11. Study sites: 20 to 21v13
  12. Site details revised at 1 of 20 sitesv12
  13. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 7 to 163 · Primary completion date: Apr 2025 to Apr 30, 2025 · Completion date: Jan 2026 to Jan 31, 2026 · 1 morev11 Show 4 more changesShow less
    • Enrollment target: 7 to 163
    • Primary completion date: Apr 2025 to Apr 30, 2025
    • Completion date: Jan 2026 to Jan 31, 2026
    • Site details revised at 20 of 20 sites
  14. Enrollment target: estimated 160 to confirmed 7 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 20 of 20 sitesv10 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 20 of 20 sites
  15. Site details revised at 1 of 20 sitesv9
  16. Site details revised at 2 of 20 sitesv8
  17. Site details revised at 6 of 20 sitesv7
  18. Site details revised at 4 of 20 sitesv6
  19. Site details revised at 5 of 20 sitesv5
  20. Site details revised at 7 of 20 sitesv4
  21. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2022 to Feb 9, 2022 · Site details revised at 20 of 20 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2022 to Feb 9, 2022
    • Site details revised at 20 of 20 sites
  22. Start date: Aug 2021 to Jan 2022v2
  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.
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition.
Trial Details
NCT Number NCT04862221
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
Conditions Acute Liver Failure, Fulminant Hepatic Failure, Hepatic Encephalopathy, Acute Liver Injury, Immune Dysregulation
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov