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Biliary Atresia Study in Infants and Children

Study acronym: BASIC
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Site details revised at 1 of 16 sitesv36
  2. Minor Re-verified, no change to tracked fieldsv35
  3. Minor Secondary endpoints: 2 to 1v34 Show 4 more changesShow less
    • Study description shortened, about 49 words
    • Site details revised at 10 of 16 sites
    • Study arms: 2 to 1
    • Eligibility criteria shortened, about 3 words
  4. Minor Primary and study completion dates: May 2029 to May 31, 2029v33
  5. Notable Primary and study completion dates: May 2024 to May 2029v32
Show 30 earlier versionsHide 30 earlier versions
  1. Minor Site contacts updated at 5 of 16 sitesv31
  2. Minor Site contacts updated at 1 of 16 sitesv30
  3. Minor Re-verified, no change to tracked fieldsv29
  4. Minor Site contacts updated at 10 of 16 sitesv28
  5. Minor Start date: May 2006 to May 16, 2006v27
  6. Notable Trial status: Suspended to Recruiting
    • Site details revised at 16 of 16 sites
    v26
  7. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Study visits suspended due to COVID-19 pandemic.
    • Site details revised at 16 of 16 sites
    v25
  8. Minor Secondary endpoints revised (2)
    • Site contacts updated at 2 of 16 sites
    v24
  9. Minor Site contacts updated at 3 of 16 sitesv23
  10. Notable Primary and study completion dates: May 2019 to May 2024
    • Study sites revised (16)
    v22
  11. Minor Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 9 words
    • Study sites revised (16)
    v21
  12. Minor Site contacts updated at 2 of 16 sitesv20
  13. Notable Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to Arbor Research Collaborative for Health
    • Site contacts updated at 12 of 16 sites
    • Collaborators expanded, about 10 words
    v19
  14. Minor Study sites: 15 to 16v18
  15. Minor Eligibility criteria shortened, about 5 wordsv17
  16. Minor Primary completion date: May 2019
    • Study completion date: Jun 2014 to May 2019
    • Study sites revised (15)
    v16
  17. Minor Enrollment target: 1200 to 1265
    • Study completion date: Dec 2012 to Jun 2014
    v15
  18. Notable Enrollment target: 500 to 1200
    • Study sites: 10 to 15
    • Study completion date: Jun 2012 to Dec 2012
    v14
  19. Minor 8 versions Re-verified since Jul 11, 2008, no change to tracked fieldsv6-v13
  20. Minor Site contacts updated at 2 of 10 sitesv5
  21. Minor 2 versions Re-verified since Feb 5, 2007, no change to tracked fieldsv3-v4
  22. Minor Site details revised at 8 of 10 sitesv2
  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.
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples to enable investigators to address the following aims: To identify the gene or genes implicated in the etiology of BA; To characterize the natural history of the older, non-transplanted child with BA.
Trial Details
NCT Number NCT00345553
Lead Sponsor Arbor Research Collaborative for Health
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
Biliary Atresia
Related terms Biliary Atresia, Cholestasis
Enrollment 1,265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov