Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Completed

Conditions studied: Liver Diseases

In brief

The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.

Key facts

Study ID

NCT04454463

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

1649

Starts

2020-11-13

Expected to finish

2025-07-09

Last updated by the study team

2025-08-13

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 2 years of age or older as of the initial screening interview and provision of consent
• Willingness to participate in the study for 1 or more years
• Histologic evidence of NAFLD or NASH based upon a standard of care liver biopsy
• Collection of serum and plasma up to 90 days before or 4- 90 days after standard of care liver biopsy
• Absence of regular or excessive use of alcohol within 2 years prior to initial screening

You may not qualify if…

• Clinical or histological evidence of alcoholic liver disease: Regular and excessive use of alcohol within the 2 years prior to interview defined as alcohol intake greater than 14 drinks per week in a man or greater than 7 drinks per week in a woman. Approximately 10 g of alcohol equals one 'drink' unit. One unit equals 1 ounce of distilled spirits, one 12-oz beer, or one 4-oz glass of wine
• Total parenteral nutrition for more than 1 month within a 6-month period before baseline liver biopsy
• Short bowel syndrome
• History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD. Bariatric surgery performed following enrollment is not exclusionary. Liver biopsies obtained during bariatric surgery cannot be used for enrollment because of the associated surgical or anesthetic acute changes and the weight loss efforts that precede bariatric surgery
• History of biliopancreatic diversion
• Evidence of advanced liver disease defined as a Child-Pugh-Turcotte score equal to or greater than 10
• Evidence of chronic hepatitis B as marked by the presence of HBsAg in serum (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
• Evidence of chronic hepatitis C as marked by the presence of anti-HCV or HCV RNA in serum
• Low alpha-1-antitrypsin level and ZZ phenotype (both determined at the discretion of the investigator)
• Wilson's disease
• Known glycogen storage disease
• Known dysbetalipoproteinemia
• Known phenotypic hemochromatosis (HII greater than 1.9 or removal of more than 4 g of iron by phlebotomy)
• Prominent bile duct injury (florid duct lesions or periductal sclerosis) or bile duct paucity
• Chronic cholestasis
• Vascular lesions (vasculitis, cardiac sclerosis, acute or chronic Budd-Chiari, hepatoportal sclerosis, peliosis)
• Iron overload greater than 3+
• Zones of confluent necrosis, infarction, massive or sub-massive, pan-acinar necrosis
• Multiple epithelioid granulomas
• Congenital hepatic fibrosis
• Polycystic liver disease
• Other metabolic or congenital liver disease
• Evidence of systemic infectious disease
• Known HIV positive
• Disseminated or advanced malignancy

Where it is running

• University of California, San Diego- Adults — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, San Diego Pediatrics — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Emory University-Pediatrics — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Indiana University- Adults — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• St. Louis University — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Texas Children's Hospital, Baylor University — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Liver Institute Northwest — Seattle, Washington, United States
• Seattle Children's Hospital- SEA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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