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

University of Copenhagen

Status: Enrolling

Conditions: Chronic Liver Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05335603

FALL

Details and patient eligibility

About

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.

Enrollment: 335 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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