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Recruiting Observational

An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis

NCT05335603 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2020-08-24
Last updated
2022-04-19

Condition(s) studied

Chronic Liver Disease

Study summary

Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Adult patients/healthy control participants (age 18 or above) who can give their informed consent * Suspected liver disease: * non-alcoholic steatohepatitis * alcoholic steatohepatitis * autoimmune hepatitis * primary biliary cholangitis * primary sclerosing cholangitis * inflammatory bowel disease * polycystic ovary syndrome * hereditary haemochromatosis * chronic pancreatitis * cystic fibrosis * alpha-1 antitrypsin deficiency Exclusion Criteria: Patients with: * malignant diseases * viral hepatitis * human immunodeficiency virus * contraindications to liver biopsy

Primary outcome measure(s)

  • Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases. — 10 years
    OMICS based analyses on plasma and liver tissue

Trial sites (1)

FacilityCityRegionStatus
Hvidovre University Hospital Hvidovre Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05335603 on ClinicalTrials.gov ↗ ← All trials in Denmark