Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Liver Diseases Clinical Trial

Official title:

Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454463
• Other study ID #: NAFLD Database 3
• Secondary ID: U01DK061732U01DK
• Status: Recruiting
• Start date: November 13, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Peggy Adamo, MS
• Phone: 410-502-9137
• Email: madamo1[@]jhu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2250
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Locations

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

Sponsors (16)

Lead Sponsor

Collaborator

Johns Hopkins Bloomberg School of Public Health

Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Case Western Reserve University, Children's Hospital Medical Center, Cincinnati, Duke University, Emory University, Indiana University, Liver Institute Northwest, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Seattle Children's Hospital, St. Louis University, University of California, San Diego, University of California, San Francisco, University of Southern California, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Nonalcoholic Steatohepatitis Clinical Research Consortium
•   The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)