Drug-Induced Liver Injury (DILI) Network Retrospective

Conditions

• Drug Induced Liver Injury

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Sep 30, 2004

Status verified

Apr 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

400 participants (estimated)

Arms

• Arm: Subjects with liver injury
• Arm: Subjects without liver injury

Primary Outcome Measure

maintain a registry of cases in the ILIAD database [ Time Frame: July 2028 ]

Central Contacts

• Eilene Pham
  919-660-7253
  [email protected]
• Matt Baum
  919-668-0486
  [email protected]

Locations (6)

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