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Discovery of biomarkers for immune-mediated liver disease.


- candidate number26984
- NTR NumberNTR7002
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mrt-2017
- Secondary IDs 
- Public TitleDiscovery of biomarkers for immune-mediated liver disease.
- Scientific TitleDiscovery of non-invasive biomarkers for immune-mediated liver diseases; AIH, DILI, NAFL and NASH.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedAutoimmune hepatitis, Non-alcoholic fatty liver disease , Non-alcoholic steatohepatitis, Drug-induced liver injury (DILI)
- Inclusion criteriaIndication 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 criteriaContraindication 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).
(a history of) alcohol or drug abuse
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2017
- planned closingdate
- Target number of participants0
- InterventionsOne extra needle passage during a liver biopsy that is part of usual care.
- Primary outcomeImmunophenotype of intrahepatic leucocytes.
- Secondary outcomeHistology outcome
- TimepointsBaseline, 6 months follow-up.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summary
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD30-mrt-2017 - 8-feb-2018


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