An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
Overview
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.
Primary outcome measures
- Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases. [Time frame: 10 years]
Secondary outcome measures (1)
- To identify any metabolic disturbances within chronic liver diseases [Time frame: Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Hvidovre University Hospital — Hvidovre
Publications
- Jensen AH, Ytting H, Nielsen AB, Werge MP, Rashu EB, Hetland LE, Thing M, Nabilou P, Burisch J, Junker AE, Hobolth L, Mortensen C, Tofteng F, Bendtsen F, Moller S, Vyberg M, Serizawa RR, Winther-Sorensen M, Kellemann JS, Gluud LL, Wewer Albrechtsen NJ. Diagnostics of Autoimmune Hepatitis Enabled by Non-Invasive Clinical Proteomics. Aliment Pharmacol Ther. 2025 Nov;62(9):901-919. doi: 10.1111/apt.7 PMID 40671462
Identifiers
NCT: NCT05335603 · FALL