Phase 4 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:

• People aged 18 to 60 years old (men or women, including those exactly 18 or 60)
• People who have been diagnosed with both chronic hepatitis B and fatty liver disease, according to specific Chinese medical guidelines
• People who have tested positive for a hepatitis B surface protein (HBsAg) in their blood for more than 6 months
• People on antiviral tablet treatment (NAs) whose HBsAg level is at or below 1500 IU/ml, who test negative for a certain hepatitis B protein (HBeAg), and whose hepatitis B virus is undetectable in the blood
• People starting injected immune-based treatment (IHC) whose HBsAg level is below 1000 IU/ml, who test negative for HBeAg, whose hepatitis B virus is undetectable, and whose liver enzyme levels (ALT and AST) have stayed consistently normal
• Women of childbearing age who have a negative pregnancy test within 24 hours before starting the treatment
• People who are willing to receive the treatment and have signed a consent form

Who may not be able to join:

• People who also have an active infection with hepatitis A, C, D, E, or HIV, or who have liver damage caused by medications, inherited liver conditions, autoimmune hepatitis, or alcohol-related liver disease
• People whose liver scans at the screening stage show a liver tumour
• People diagnosed with hepatitis B-related liver cirrhosis (scarring of the liver), based on a liver biopsy or meeting two or more specific signs of liver cirrhosis (confirm with trial site)
• Women who are pregnant, breastfeeding, planning to become pregnant, or unwilling to use contraception during the study
• People with low white blood cell counts (neutrophils below 1.5×10⁹/L), low platelet counts (below 90×10⁹/L), or kidney function markers (creatinine) above 1.5 times the normal upper limit
• People — or their close relatives such as parents or siblings — who have a history of serious mental illness, particularly severe depression, psychosis, suicide attempts, or hospitalisation due to mental illness
• People with a history of immune system conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, severe psoriasis, or similar conditions, or who have abnormally high levels of autoimmune markers in the blood
• People with serious conditions affecting the heart, lungs, kidneys, brain, or blood, or who have any other cancer
• People with a history of severe epilepsy or who are currently taking epilepsy medication, or who have poorly controlled diabetes, high blood pressure, or thyroid disease, or who have a history of serious eye (retina) problems
• People who have had an organ transplant and still have a functioning transplanted organ (corneal or hair transplants are exceptions)
• People who are allergic to interferon or its ingredients, or whom the trial doctor considers unsuitable for interferon treatment
• People whom the trial investigator considers ineligible for any other reason

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