Status:
COMPLETED
Nonalcoholic Fatty Liver Disease (NAFLD) Database 3
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Conditions:
Liver Diseases
Eligibility:
All Genders
2+ years
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 o...
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 inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
1649 Patients enrolled
Trial Details
Trial ID
NCT04454463
Start Date
November 13 2020
End Date
July 9 2025
Last Update
August 13 2025
Active Locations (16)
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1
University of California, San Diego- Adults
La Jolla, California, United States, 92103
2
University of Southern California
Los Angeles, California, United States, 90089
3
University of California, San Diego Pediatrics
San Diego, California, United States, 92103
4
University of California, San Francisco
San Francisco, California, United States, 94143