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Nonalcoholic Fatty Liver Disease (NAFLD) Database 3 | Clinical Trials | Clareo Health

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Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

NCT04454463•Johns Hopkins Bloomberg School of Public Health

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

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

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
+19 more criteria

Locations (16)

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

Key Dates

Start Date

November 13, 2020

Primary Completion Date

July 9, 2025

Completion Date

July 9, 2025

Last Updated

August 13, 2025

Enrollment

1,649

ACTUAL participants

Conditions

Liver Diseases

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NCT05264051

Liver Diseases

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RECRUITINGNA

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

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Liver Diseases, AlcoholicAlcohol Use Disorder+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Inclusion Criteria

Exclusion Criteria

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