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

Chronic Liver Disease Clinical Trial

— FALL  

Official title:

Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335603
• Other study ID #: FALL
• Status: Recruiting
• Start date: August 24, 2020
• Est. completion date: August 2036

Study information

• Verified date: April 2022
• Source: University of Copenhagen
• Contact: Anne-Sofie H Jensen, MD
• Phone: +4538621966
• Email: anne-sofie.houlberg.jensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: August 2036
• Est. primary completion date: August 2036
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Fatty Liver
• Liver Diseases

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fibrosis stage of the liver	Non-invasive scoring systems (e.g. Fibroscan, Fib-4)	10 years
Primary	Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.	OMICS based analyses on plasma and liver tissue	10 years
Secondary	To identify any metabolic disturbances within chronic liver diseases	Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones	Plasma obtained at time point 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min.