Evaluating patients with chronic liver diseases linked to fat accumulation in the liver
Official title: Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
Run by University of Copenhagen · NCT05335603 · Data updated 2026-11-12
This study is trying to understand how fat buildup in the liver affects people with chronic liver diseases to help find better ways to diagnose and treat these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 335 (estimated) |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Hvidovre) |
| Status | Recruiting |
| Started | August 24, 2020 |
| Main results expected | August 2036 |
| Study ends | August 2036 |
| Registry record updated | April 19, 2022 |
| Trial ID | NCT05335603 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and above with suspected liver diseases such as non-alcoholic steatohepatitis or autoimmune hepatitis.
✕Probably not a fit
Patients with malignant diseases, viral hepatitis, or contraindications to liver biopsy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with chronic liver diseases associated with hepatic steatosis, which can lead to serious complications like cirrhosis and liver failure. The study aims to perform in-depth phenotyping at a tissue level to better understand the underlying mechanisms of these diseases and identify potential biomarkers for diagnosis and treatment. It includes adult patients suspected of having various liver conditions, such as non-alcoholic steatohepatitis and autoimmune hepatitis. The research will help clarify the relationship between hepatic steatosis and other chronic liver diseases.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and targeted treatments for patients with chronic liver diseases.
How similar studies have gone: Other studies have shown promise in understanding chronic liver diseases through similar observational approaches, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hvidovre University Hospital
Hvidovre, Denmark Recruiting
Study contacts
- Principal investigator: Lise L Gluud, Professor — Hvidovre University Hospital
- Study coordinator: Anne-Sofie H Jensen, MD
- Email: anne-sofie.houlberg.jensen@regionh.dk
- Phone: +4538621966
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
Understanding how chronic liver disease patients with organ failure fare after non‑emergency hospital stays
This study follows adults with chronic liver disease who are admitted to the hospital non-electively to see how their condition develops over six months when liver and/or other organs fail.
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Understanding social and health needs of people with chronic liver disease in outpatient care
This project will see how common social needs are and whether adults with chronic liver disease want their outpatient providers to help with them.
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Using rifaximin to improve liver transplant outcomes
This study is testing if taking the antibiotic rifaximin before and after liver transplant surgery can help prevent early problems with the new liver in adults.
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Endoscopic ultrasound shear wave elastography for measuring liver fibrosis
This study will test whether endoscopic ultrasound shear wave elastography and attenuation imaging can estimate liver fibrosis compared with biopsy and FibroScan in adults with suspected MASLD or MASH.
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Comparing intravenous and under-skin LAENNEC for alcoholic and non-alcoholic fatty liver disease
This will test whether 10 ml intravenous LAENNEC given twice weekly for six weeks works better and is as safe as 4 ml subcutaneous LAENNEC in adults 19–70 with alcoholic or non‑alcoholic fatty liver disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.