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NCT Number: NCT05335603

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

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.

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Key information

Conditions

Chronic Liver Disease Autoimmune Diseases Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Cholestasis Cholestasis, Intrahepatic Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Fatty Liver Fibrosis Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Hemochromatosis Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Iron Metabolism Disorders Iron Overload Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases.

    Time frame: 10 years

    OMICS based analyses on plasma and liver tissue

Secondary outcomes

  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.

    Collection of plasma during an oral glucose tolerance test measuring pancreatic and gut hormones

Other outcomes

  1. Fibrosis stage of the liver

    Time frame: 10 years

    Non-invasive scoring systems (e.g. Fibroscan, Fib-4)

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Sofie H Jensen, MD

CONTACT

[email protected]

+4538621966

Lise L Gluud, Professor

CONTACT

[email protected]

+4538621964

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study title

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

Acronym: FALL

Important dates

Study start
2020
Primary completion
2036
Study completion
2036
First posted
Apr 19, 2022
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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