Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

This trial includes several different groups of people. You may qualify if you fit into one of the following groups:

Group 1 – Alcohol-related fat in the liver (no scarring or inflammation):

• You drink more than 60g of alcohol per day (if male) or more than 40g per day (if female), and have fat built up in your liver but no scarring or inflammation
• Your liver blood tests show abnormal results suggesting liver problems

Group 2 – Alcoholic hepatitis with mild liver scarring:

• You have fat in your liver plus signs of liver cell damage, and mild scarring (stage 1–2) confirmed by biopsy
• There are signs of immune cell activity (inflammation) in the liver

Group 3 – Alcoholic hepatitis with advanced liver scarring:

• You have fat in your liver plus signs of liver cell damage, and more advanced scarring (stage 3–4) confirmed by biopsy
• There are signs of immune cell activity (inflammation) in the liver

Group 4 – Alcoholic cirrhosis (severe liver scarring):

• You have stage 4 liver scarring and complications such as enlarged veins in the food pipe, an enlarged spleen, or fluid build-up in the abdomen

Group 5 – Alcoholic cirrhosis with liver cancer:

• You have cirrhosis AND liver cancer (diagnosed by tissue sample or specialised scan)

Group 6 – Non-alcoholic fatty liver disease (NASH):

• You have a liver condition called NASH confirmed by a liver biopsy, and/or chronic liver disease related to Hepatitis C

Group 7 – Healthy volunteers:

• You score below 4 (men) or below 3 (women) on a standard alcohol use questionnaire called the AUDIT-C

Who may not be able to join:

For the alcohol-related liver disease groups (Groups 1–5):

• Your Body Mass Index (BMI) is over 35
• You have Hepatitis B
• You have a condition called haemochromatosis (too much iron in the body)
• You have Wilson's disease (a condition affecting copper in the body)
• You have autoimmune hepatitis (where the immune system attacks the liver)
• Your liver disease was caused by a medication
• You have Hepatitis C
• You have a condition called alpha-1 antitrypsin deficiency
• You are not willing to sign a consent form to take part

For the NASH group (Group 6):

• You have any type of cancer
• You have diabetes
• You have high blood pressure
• You have heart disease or have had a stroke
• You have a past history of liver disease
• You have Hepatitis C
• You have alpha-1 antitrypsin deficiency
• You drink fewer than 7 drinks per week (women) or fewer than 14 drinks per week (men) (confirm with trial site)
• Your BMI is over 35

For healthy volunteers (Group 7):

• You have any type of cancer (except certain common skin cancers)
• You have diabetes
• You have high blood pressure
• You have high cholesterol
• You have heart disease or have had a stroke
• You have any current or past liver disease of any kind
• Your BMI is over 27 kg/m²

Important: Always verify eligibility with the trial site directly before applying.