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A Prospective Database of Infants With Cholestasis

Study acronym: PROBE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Site details revised at 1 of 16 sitesv35
  2. Minor Re-verified, no change to tracked fieldsv34
  3. Minor Study description shortened, about 178 words
    • Site details revised at 10 of 16 sites
    • Study arms: 2 to 1
    • Eligibility criteria shortened, about 2 words
    v33
  4. Minor Primary and study completion dates: May 2029 to May 31, 2029v32
  5. Notable Primary and study completion dates: May 2024 to May 2029v31
Show 29 earlier versionsHide 29 earlier versions
  1. Minor Site contacts updated at 4 of 16 sitesv30
  2. Minor Site contacts updated at 1 of 16 sitesv29
  3. Minor Re-verified, no change to tracked fieldsv28
  4. Minor Site contacts updated at 10 of 16 sitesv27
  5. Minor Start date: May 2004 to Apr 21, 2004v26
  6. Notable Trial status: Suspended to Recruiting
    • Site details revised at 16 of 16 sites
    v25
  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
    v24
  8. Minor Eligibility criteria expanded, about 6 words
    • Study description expanded, about 13 words
    • Site contacts updated at 3 of 16 sites
    v23
  9. Minor Site contacts updated at 3 of 16 sitesv22
  10. Notable Primary and study completion dates: May 2019 to May 2024
    • Site contacts updated at 3 of 16 sites
    v21
  11. Minor Study description shortened, about 12 words
    • Study sites revised (16)
    • Study title shortened, about 1 word
    v20
  12. Minor Site contacts updated at 2 of 16 sitesv19
  13. Notable Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to Arbor Research Collaborative for Health
    • Site contacts updated at 8 of 16 sites
    • Collaborators expanded, about 10 words
    • Study title expanded, about 4 words
    v18
  14. Minor Study sites: 15 to 16
    • Eligibility criteria expanded, about 147 words
    • Study description expanded, about 424 words
    v17
  15. Minor Primary and study completion dates: May 2019
    • Study sites revised (15)
    v16
  16. Notable Enrollment target: 400 to 1000
    • Study sites: 14 to 15
    v15
  17. Minor Study sites: 10 to 14v14
  18. Minor 6 versions Re-verified since Jul 11, 2008, no change to tracked fieldsv8-v13
  19. Minor Site contacts updated at 3 of 10 sitesv7
  20. Minor 2 versions Re-verified since Dec 11, 2006, no change to tracked fieldsv5-v6
  21. Minor Study sites revised (10)v4
  22. Minor Study sites: 9 to 10
    • Start date: May 2004
    v3
  23. Minor Re-verified, no change to tracked fieldsv2
  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.
Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Childhood Liver Disease Research Network (ChiLDReN) is to establish a database of clinical information and plasma, serum, and tissue samples from cholestatic children to facilitate research and to perform clinical, epidemiological and therapeutic trials in these important pediatric liver diseases.
Trial Details
NCT Number NCT00061828
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
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov