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NotablePrimary completion date: Aug 2013 to Jul 2017Completion date: Aug 2013 to Jul 2018 · Site contacts updated at 1 of 8 sitesv13Show 2 more changesShow less
Minor3 versionsRe-verified since Aug 7, 2012, no change to tracked fieldsv9-v11
MinorSite details revised at 2 of 8 sitesv8
MinorRe-verified, no change to tracked fieldsv7
NotableEnrollment target: 450 to 900Study sites: 5 to 8 · Primary completion date: Aug 2013 · Completion date: Aug 2008 to Aug 2013 · 2 morev6Show 5 more changesShow less
MinorEligibility criteria shortened, about 85 wordsStudy description shortened, about 23 words · Site contacts updated at 1 of 5 sites · Publications: 19 to 11v2Show 3 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.
Trial Details
NCT Number
NCT00345930
Lead Sponsor
Duke University Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)