Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
11 other identifiers
observational
1,649
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2025
CompletedAugust 13, 2025
August 1, 2025
4.7 years
June 5, 2020
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in alanine aminotransferase (ALT) levels from baseline to one year.
ALT measure in IU/L (higher ALT indicates worse outcomes)
Baseline and 1 year
Study Arms (2)
Adult patients with NAFLD
1500 patients 18 years and older at the time of enrollment.
Pediatric patients with NAFLD
750 patients 2 years or older and up to 17 years old at the time of enrollment.
Eligibility Criteria
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.
You may qualify if:
- 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 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Bloomberg School of Public Healthlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Baylor College of Medicinecollaborator
- Case Western Reserve Universitycollaborator
- Duke Universitycollaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
- Indiana Universitycollaborator
- Liver Institute Northwestcollaborator
- Seattle Children's Hospitalcollaborator
- St. Louis Universitycollaborator
- University of California, San Diegocollaborator
- University of California, San Franciscocollaborator
- University of Southern Californiacollaborator
- Virginia Commonwealth Universitycollaborator
- Emory Universitycollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
Study Sites (16)
University of California, San Diego- Adults
La Jolla, California, 92103, United States
University of Southern California
Los Angeles, California, 90089, United States
University of California, San Diego Pediatrics
San Diego, California, 92103, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Emory University-Pediatrics
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
Indiana University- Adults
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
St. Louis University
St Louis, Missouri, 63110, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Texas Children's Hospital, Baylor University
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Liver Institute Northwest
Seattle, Washington, 98105, United States
Seattle Children's Hospital- SEA
Seattle, Washington, 98105, United States
Related Links
Biospecimen
plasma, serum, liver tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arun Sanyal, MD
Virginia Commonwealth University Medical Center
- PRINCIPAL INVESTIGATOR
Brent Tetri, MD
St Louis University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
July 1, 2020
Study Start
November 13, 2020
Primary Completion
July 9, 2025
Study Completion
July 9, 2025
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- Within two years of end of the funding cycle.
- Access Criteria
- All qualified investigators will be allowed access to the stored materials at the end of a pre-determined proprietary period.
The NASH CRN is fully committed to resource sharing beyond the NASH CRN investigators. The NASH CRN will make deposits to the NIDDK Central Data Repository according to the requirements outlined in the NIDDK Data Sharing Policy published in July 2013.