Clinical trial NCT04454463: Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
Official title: Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Diseases
Keywords: NAFLD
NASH
non-alcoholic steatohepatitis
fatty liver disease
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Baylor College of Medicine
name: Case Western Reserve University
name: Duke University
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Indiana University
name: Liver Institute Northwest
name: Seattle Children's Hospital
name: St. Louis University
name: University of California, San Diego
name: University of California, San Francisco
name: University of Southern California
name: Virginia Commonwealth University
name: Emory University
name: Children's Hospital Medical Center, Cincinnati
First posted: 2020-07-01
Enrollment: 1649
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be at least 2250 patients age 2 years or older with histologically confirmed NAFLD or NASH located in the United States:

* 1500 patients 18 years and older at the time of enrollment.
* 750 patients 2 years or older and up to 17 years old at the time of enrollment.

Brief summary: 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.

Detailed description: This is a multicenter, prospective follow-up study of patients with known nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). The primary objective of the study is to investigate the etiology, pathogenesis, natural history, diagnosis, treatment, and prevention of NAFLD and NASH.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up
* Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
* Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of study
* Inability to complete the appropriate informed consent process

Primary outcomes:
measure: Change in alanine aminotransferase (ALT) levels from baseline to one year.
timeFrame: Baseline and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego- Adults
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: University of California, San Diego Pediatrics
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Atlanta
country: United States
facility: Emory University-Pediatrics
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University- Adults
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor University
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital- SEA
state: Washington
Study officials:
affiliation: Virginia Commonwealth University Medical Center
name: Arun Sanyal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Louis University Hospital
name: Brent Tetri, MD
role: PRINCIPAL_INVESTIGATOR
References: