DILIN - Prospective Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Duke University
Study ID
NCT00345930
Status
Recruiting
Apply to this trial

Conditions

  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Jun 29, 2006
Start date
Sep 30, 2004
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
4,000 participants (estimated)

Arms

  • Arm: 2
    Individuals without drug induced liver disease
  • Arm: 1
    Individuals with drug induced liver disease

Primary Outcome Measure

Develop a database of recent DILI cases [ Time Frame: July 2028 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Susan Milstein, RN, BSN
[email protected]
323-224-5441
Andrew Stolz, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202-5111
Jennifer Terrell
[email protected]
317-278-6266
Naga P Chalasani, MD (PRINCIPAL_INVESTIGATOR)
NIH Clinical SiteBethesdaMaryland20892
Jaha nor
[email protected]
301-435-6122
Christopher Koh, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109-0362
Josefa Kaganove
[email protected]
Robert J Fontana, MD (PRINCIPAL_INVESTIGATOR)
Univeristy of North Carolina at Chapel HillChapel HillNorth Carolina27599-7600
Jacquee Simpson
[email protected]
None Available
Paul B Watkins, MD (PRINCIPAL_INVESTIGATOR)
Thomas JeffersonPhiladelphiaPennsylvania19141
Katrin Koy
[email protected]
215-456-2004
Dina Halegoua-DeMarzio, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Southern California· Los Angeles, CAIndiana University· Indianapolis, INNIH Clinical Site· Bethesda, MDUniversity of Michigan· Ann Arbor, MIUniveristy of North Carolina at Chapel Hill· Chapel Hill, NCThomas Jefferson· Philadelphia, PA

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