DILIN - Prospective Study

ConditionLiver Diseases

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age2+

SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 2 years at enrollment into the study.

Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment.

Written Informed consent from the patient or the patient's legal guardian.

ALT or AST >5 x ULN or A P'ase >2 x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values.

Disqualifiers

Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology.

Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI.

Acetaminophen hepatotoxicity.

Liver/bone marrow transplant prior to the development of drug- or CAM-induced liver injury.

Trial population

Patients who have suffered a drug induced liver injury and meet inclusion and exclusion criteria

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants

are grouped into 2 trial groups

Group A: 2

Group B: 1

Trial outcomes

Primary outcomes

Develop a database of recent DILI cases

develop a database of recent DILI cases

Time frame

July 2028

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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