Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT03282305
Eligibility Criteria:
Inclusion Criteria:
* 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:
1. 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);
2. A definite diagnosis of NASH will be defined by steatohepatitis confirmed by biopsy with correlating clinical evidence of non-alcoholic liver disease;
3. 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 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. gastroplasty, roux-en-Y gastric bypass).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT03282305
Study Brief:
Protocol Section:
NCT03282305