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

  • End date
    Aug 29, 2036
  • participants needed
  • sponsor
    University of Copenhagen
Updated on 29 April 2022
Accepts healthy volunteers


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.

Condition Chronic Liver Disease
Clinical Study IdentifierNCT05335603
SponsorUniversity of Copenhagen
Last Modified on29 April 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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