Discovery of non-invasive biomarkers for immune-mediated liver diseases; AIH, DILI, NAFL and NASH.

• Conditions: autoimmune hepatitis; drug-induced liver injury; non-alcoholic fatty liver disease and non-alcoholic steatohepatitis; 10019654; 10003816

• Registration Number: NL-OMON43305
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Indication for a biopsy for the diagnosis or monitoring of; AIH, DILI, NAFL or NASH
* Eligible for liver biopsy
* * 18 years old
* Provide informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Contraindication for liver biopsy, determined by the clinician.
* Current infectious disease.
* Clinically relevant cardiovascular, pulmonary, or renal disease.
* Medications with possible immune-modulating effects (e.g., steroids).
* History of alcohol or drug abuse.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Immunophenotype of intrahepatic and peripheral blood leukocytes. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Histology assessment of liver biopsy<br /><br>Serology<br /><br>Clinical Chemistry and Hematology laboratory results<br /><br>Treatment regime<br /><br>Occurrence of (serious) adverse events</p><br>