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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43305
Enrollment
100
Registered
2016-12-14
Start date
2016-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autoimmune hepatitis drug-induced liver injury non-alcoholic fatty liver disease and non-alcoholic steatohepatitis

Interventions

Hepatology
immune mediated
Liver disease

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Immunophenotype of intrahepatic and peripheral blood leukocytes.

Secondary

MeasureTime frame
Histology assessment of liver biopsy Serology Clinical Chemistry and Hematology laboratory results Treatment regime Occurrence of (serious) adverse events

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)