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Report for Clinical Trial NCT03282305

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Prospective Cohort Assessing the Prevalence and Progress of Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH) in Chinese

Nonalcoholic fatty liver disease (NAFLD) is a progressive liver disease ranging from simple steatosis to cirrhosis of the liver. Nonalcoholic fatty liver (NAFL) without substantial hepatocellular injury is thought to be relatively benign whereas nonalcoholic steatohepatitis (NASH) is characterized by hepatocyte steatosis, ballooning, inflammation and varying degrees of fibrosis from none to cirrhosis. NASH is strongly associated with insulin resistance and metabolic syndrome and thus is recognized as a major public health concern as the most prevalent liver disease. Liver biopsy is the gold standard for a diagnosis of NASH. However, given the large population of patients at risk for NASH, liver biopsy is not a practical method for determining which patients may benefit from NASH therapy. Non-invasive methods to estimate inflammation and fibrosis are in clinical use, but there remains a dichotomy between gold standard inclusion criteria and end points that are utilized in clinical trials and real world diagnostic methods that are more common in clinical practice. Thus, the investigators would like to conduct an observational study to head-to-head compare the non-invasive methods and liver biopsy in differential liver steatosis and liver biopsy in a real-world setting. Also, by following up patients for a relatively long time (proposed 10 years), the investigators can present the natural history of disease progression.

NCT03282305 Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis
MeSH:Fatty Liv Fatty Liver Non-alcoholic Fatty Liver Disease
HPO:Hepatic steatosis

Primary Outcomes

Description: The change in NASH Clinical Research Network (CRN) score based on liver biopsy

Measure: Histological endpoint

Time: 10 years

Secondary Outcomes

Description: Number of all-cause death

Measure: Number of all-cause death

Time: 10 years

Description: Number of liver-related death

Measure: Number of liver-related death

Time: 10 years

Description: Number of liver transplant

Measure: Number of liver transplant

Time: 10 years

Description: Number of hepatocellular carcinoma (HCC)

Measure: Number of hepatocellular carcinoma (HCC)

Time: 10 years

Time Perspective: Prospective


There is one SNP


1 C282Y

Exclusion Criteria: - Unable to provide written informed consent (or assent in pediatric subjects) - Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is half pint of beer [285 mL; 9.64 oz], 1 glass of spirits [25 mL; 0.85 oz] or 1 glass of wine [125 mL; 4.23 oz] - Enrolled in NASH-related clinical trials - Presence of other forms of chronic liver disease: 1. Chronic hepatitis B (HBsAg positive) 2. Chronic hepatitis C (HCV RNA positive) 3. Iron overload disorders (3-4+ iron on liver biopsy or known hemochromatosis gene (HFE) C282Y homozygous with ferritin > 200 ng/ml; note: an elevated ferritin alone is common in NASH and is not exclusionary) 4. Autoimmune liver disease (biopsy evidence or clinical diagnosis of autoimmune hepatitis or Primary biliary cholangitis (PBC) requiring ongoing treatment, imaging evidence of Primary sclerosing cholangitis (PSC)) 5. Wilson's disease 6. Alpha-1 antitrypsin mutations that in the opinion of the principal investigator is contributing to the patient's liver disease; - Prior bariatric surgery unless the surgery was performed more than one year before the biopsy diagnosis of NASH (i.e., NASH is present despite prior bariatric surgery); - Planned bariatric surgery (e.g. --- C282Y ---

HPO Nodes