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NCT00360646 · ClinicalTrials.gov registry record

Drug-Induced Liver Injury (DILI) Network Retrospective

A clinical trial of Drug Induced Liver Injury, sponsored by Duke University.

Recruiting
Registry status
400
Enrollment target
6
Study locations

NCT00360646: Recruiting study of Drug Induced Liver Injury, sponsored by Duke University.

NCT00360646 is a study of Drug Induced Liver Injury that is actively recruiting participants, run by Duke University. The registered enrollment target is 400 participants. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00360646, a study of Drug Induced Liver Injury, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
400 participants
Enrollment target
6
Study locations

Study Summary

The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI and the relevant clinical data concerning the episode of DILI; and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as living immune cells for phenotyping studies. A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be recontacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI.

Primary Outcome

maintain a registry of cases in the ILIAD database

Conditions Studied

Study Locations (6)

California

  • University of Southen California - Los Angeles

Indiana

  • Indiana University - Indianapolis

Maryland

  • NIH Clinical Site - Bethesda

Michigan

  • University of Michigan - Ann Arbor

North Carolina

  • Univeristy of North Carolina at Chapel Hill - Chapel Hill

Pennsylvania

  • Thomas Jefferson - Philadelphia

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2004-09
Est. Completion 2028-07-31
Duke University

1,725 total trials

What NCT00360646 shows while recruiting

NCT00360646 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Drug Induced Liver Injury appearing as the primary indexed condition, and to 0 interventions.

NCT00360646 lists 6 locations in 6 states (California, Indiana, Maryland).

Frequently Asked Questions

What is clinical trial NCT00360646 about?

NCT00360646 is a clinical study titled "Drug-Induced Liver Injury (DILI) Network Retrospective". The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigat...

What is the current status of trial NCT00360646?

This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2004-09. Estimated completion is 2028-07-31.

What conditions does trial NCT00360646 study?

This clinical trial studies the following conditions: Drug Induced Liver Injury.

Who is sponsoring clinical trial NCT00360646?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00360646 being conducted?

This trial has 6 study locations across California, Indiana, Maryland, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00360646, the US trial registry maintained by the National Library of Medicine. NCT00360646 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.