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NCT03282305Not yet recruiting

Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese

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

Source: ClinicalTrials.gov · Last updated 6 Feb 2018 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
12 Sept 2017
Start date
1 Apr 2018
Primary completion date
31 Dec 2028
Lead sponsor
Great China Fatty Liver Consortium Limited
NCT number
NCT03282305

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 1 Apr 2018 to the primary completion date, 31 Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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. gastroplasty, roux-en-Y gastric bypass).

Other illness

  • Presence of other forms of chronic liver disease:
    • Chronic hepatitis B (HBsAg positive)
    • Chronic hepatitis C (HCV RNA positive)
    • 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)
    • 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))
    • Wilson's disease
    • Alpha-1 antitrypsin mutations that in the opinion of the principal investigator is contributing to the patient's liver disease;

Other

  • 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

Who the study is looking for

  • Adults and children subjects aged \>= 6 years old
  • Ability to understand and sign a written informed consent form (ICF) or provide assent in pediatric subjects
  • Diagnosis of NAFLD; or a definite or probable diagnosis of NASH:
    • A diagnosis of NAFLD will be defined by evidence of hepatic steatosis, either by imaging or by histology, with no causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steato-genic medication (e.g. valproate, amiodarone, anti-retroviral medications, tetracycline, chronic high-dose corticosteroids), or hereditary disorders (e.g. Wilson's disease, Wolman disease, cholesteryl-ester storage disease);
    • A definite diagnosis of NASH will be defined by steatohepatitis confirmed by biopsy with correlating clinical evidence of non-alcoholic liver disease;
    • A probable diagnosis of NASH will be defined by:
    • a.Elevated alanine amino transferase levels (ALT) of \>40 U/L; and b.Evidence of hepatic steatosis on imaging; or c.Obesity, type 2 diabetes, or pre-diabetes. Pre-diabetes is defined by: i.Impaired fasting glucose: 100 mg/dL-125 mg/dL (5.6 mmol/L-6.9 mmol/L) or; ii.Impaired glucose tolerance: 2-hr plasma glucose (PG) in 75-g Oral Glucose Tolerance Test (OGTT) 140 mg/dL-199 mg/dL (7.8 mmol/L-11.0 mmol/L) or; iii.HbA1C: 5.7%-6.4%.

Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.