Evaluating patients with chronic liver diseases linked to fat accumulation in the liver
Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis
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 |
|---|---|
| Enrollment | 335 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT05335603 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and above with suspected liver diseases such as non-alcoholic steatohepatitis or autoimmune hepatitis.
Not a fit: Patients with malignant diseases, viral hepatitis, or contraindications to liver biopsy may not benefit from this study.
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 performed: Other studies have shown promise in understanding chronic liver diseases through similar observational approaches, indicating potential for success.
Eligibility criteria
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 this trial is running
Hvidovre
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.