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Primary Sclerosing Cholangitis in Children

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv18
  2. Site details revised at 1 of 12 sitesv17
  3. Site details revised at 9 of 12 sitesv16
  4. Primary and study completion dates: May 2029 to May 31, 2029
    • Site contacts updated at 3 of 12 sites
    v15
  5. Primary and study completion dates: May 2024 to May 2029v14
Show 12 earlier versionsHide 12 earlier versions
  1. Site contacts updated at 1 of 12 sitesv13
  2. Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 1 of 3 entries
    v12
  3. Site contacts updated at 4 of 12 sitesv11
  4. Re-verified, no change to tracked fieldsv10
  5. Site details revised at 9 of 12 sitesv9
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2021 to Dec 30, 2021
    • Site details revised at 12 of 12 sites
    v8
  7. Start date: Jul 2021 to Dec 31, 2021v7
  8. Start date: Mar 2021 to Jul 2021v6
  9. Start date: Dec 2020 to Mar 2021v5
  10. Start date: May 2020 to Dec 2020v4
  11. Start date: Jan 2020 to May 2020
    • Study sites: 13 to 12
    v3
  12. Secondary endpoints revised (3)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver. The purposes of this study are to: * Collect medical and other data to learn more about PSC, how it progresses, and identify factors that may cause the disease to progress more quickly. * Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning * Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.
Trial Details
NCT Number NCT04181138
Lead Sponsor Arbor Research Collaborative for Health
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Primary Sclerosing Cholangitis, Liver Diseases, Cholangitis, Sclerosing
Related terms Cholangitis, Sclerosing, Liver Diseases
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov