Status:
NOT_YET_RECRUITING
Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese
Lead Sponsor:
Great China Fatty Liver Consortium Limited
Collaborating Sponsors:
Chinese University of Hong Kong
Virginia Commonwealth University
Conditions:
Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
6+ years
Brief Summary
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 inju...
Detailed Description
GC-FLC is a cooperative consortium of principal investigators from academic institutions and community-based sites treating patients with NAFLD and NASH. The investigators will leverage the multidisci...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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:
- 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;
- 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).
Key Trial Info
Start Date :
April 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT03282305
Start Date
April 1 2018
End Date
December 1 2029
Last Update
February 6 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.