MinorPrimary and study completion dates: Jun 2028 to Jul 31, 2028v29
NotablePrimary and study completion dates: Jun 2023 to Jun 2028v28
Show 26 earlier versionsHide 26 earlier versions
NotableEnrollment target: 1600 to 4000v27
MinorSite contacts updated at 2 of 6 sitesv26
MinorSite contacts updated at 4 of 6 sitesv25
Re-verified, no change to tracked fieldsv24
MinorSite contacts updated at 2 of 6 sitesv23
NotablePrimary and study completion dates: Jul 2022 to Jun 2023
Site contacts updated at 3 of 6 sites
v22
NotablePrimary and study completion dates: Jul 2018 to Jul 2022
Site contacts updated at 2 of 6 sites
v21
NotablePrimary completion date: Jul 2017 to Jul 2018v20
MinorSite contacts updated at 2 of 6 sitesv19
MinorStudy description expanded, about 3 wordsv18
MinorSite contacts updated at 1 of 6 sites
Study description expanded, about 5 words
v17
NotableEnrollment target: 900 to 1600v16
MinorSite contacts updated at 2 of 6 sitesv15
MinorStudy sites: 8 to 6v14
NotablePrimary completion date: Aug 2013 to Jul 2017
Study completion date: Aug 2013 to Jul 2018
Site contacts updated at 1 of 8 sites
v13
MinorStudy sites revised (8)v12
3 versionsRe-verified since Aug 7, 2012, no change to tracked fieldsv9-v11
MinorSite details revised at 2 of 8 sitesv8
Re-verified, no change to tracked fieldsv7
NotableEnrollment target: 450 to 900v6Show 5 more changesShow less
Study sites: 5 to 8
Primary completion date: Aug 2013
Study completion date: Aug 2008 to Aug 2013
Publications: 11 to 13
Eligibility criteria expanded, about 1 word
MinorEnrollment target: 450
Site contacts updated at 2 of 5 sites
v5
MinorStudy completion date: May 2008 to Aug 2008
Site contacts updated at 2 of 5 sites
v4
MinorStudy description shortened, about 29 wordsv3
MinorEligibility criteria shortened, about 85 words
Study description shortened, about 23 words
Site contacts updated at 1 of 5 sites
Publications: 19 to 11
v2
Study First Submitted
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)