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Alpha-1 Antitrypsin Deficiency Adult Liver Study

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Dec 2025 to Dec 2027
    • Study completion date: Jul 2026 to Dec 2027
    v19
  2. Primary completion date: Jul 2025 to Dec 2025v18
  3. Study description expanded, about 34 wordsv17
  4. Primary completion date: Sep 2023 to Jul 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Sep 2023 to Jul 2026
    • Site details revised at 3 of 3 sites
    v16
  5. 2 versions Re-verified since Feb 14, 2022, no change to tracked fieldsv14-v15
Show 12 earlier versionsHide 12 earlier versions
  1. Trial status: Suspended to Recruiting
    • Primary and study completion dates: Dec 2021 to Sep 2023
    • Site details revised at 3 of 3 sites
    v13
  2. Trial status: Recruiting to Suspended Sponsor's reason: Study visits suspended due to COVID-19 pandemic.
    • Site details revised at 3 of 3 sites
    v12
  3. Primary completion date: Aug 2020 to Dec 2021
    • Study completion date: Aug 2021 to Dec 2021
    • Site contacts updated at 1 of 3 sites
    v11
  4. Site contacts updated at 1 of 3 sitesv10
  5. Re-verified, no change to tracked fieldsv9
  6. Enrollment target: 100 to 120v8 Show 5 more changesShow less
    • Interventions: Liver Biopsy (Procedure) to Liver Biopsy (Biopsy Group Only) (Procedure)
    • Eligibility criteria expanded, about 345 words
    • Study description expanded, about 136 words
    • Site contacts updated at 1 of 3 sites
    • Study arms: 1 to 3
  7. Re-verified, no change to tracked fieldsv7
  8. Site contacts updated at 2 of 3 sitesv6
  9. Site details revised at 1 of 3 sitesv5
  10. Site contacts updated at 1 of 3 sitesv4
  11. Study sites revised (3)
    • Collaborators: 6 to 5
    v3
  12. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators hypothesize that there is liver injury (inflammation, fibrosis, cirrhosis) in adults with Alpha-1 Antitrypsin Deficiency (AATD), which is asymptomatic, under-recognized, and undiagnosed. In addition, the investigators believe that the genetic and environmental factors that play an important role in the development of alpha-1 antitrypsin (AAT) liver disease, can be identified by comparing a cohort database of clinical disease information to linked biospecimen and DNA samples.
Trial Details
NCT Number NCT02014415
Lead Sponsor St. Louis University
Collaborators: Alpha-1 Foundation, University of California, Boston University, University College, London, University of Massachusetts, Worcester
Conditions
(from sponsor)		 Alpha-1 Antitrypsin Deficiency
Related terms alpha 1-Antitrypsin Deficiency, Fibrosis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov