NAFLD Pediatric Database 2

Completed

Conditions studied: Liver Disease

In brief

The NAFLD Database 2 will recruit at least 650 new pediatric participants with liver biopsies and contemporaneous biosamples, and will also invite pediatric participants from the prior NAFLD Database and TONIC trial (50 with a recent biopsy and 150 without a contemporaneous biopsy) to enroll in the NAFLD Pediatric Database 2 study. Combining the new and continuing participants leads to a recruitment goal for the pediatric Database 2 of 850 pediatric participants during the enrollment period.

Key facts

Study ID

NCT01061684

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

969

Starts

2010-01-20

Expected to finish

2020-05-31

Last updated by the study team

2022-02-23

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Continuing participants:
• Previously enrolled in the NAFLD Database study or TONIC trial
• Age at least 2 years and not older than 17 years during the consent process
• Willingness to continue to be followed for up to 4 years
• Ability and willingness to give written, informed parental consent and child assent, per local IRB guidelines, to be enrolled into the pediatric Database 2 study
• New participants:
• Age at least 2 years of age and not older than 17 years during the consent process
• Willingness to be followed for up to 4 years
• Ability and willingness to give written, informed parent consent and child assent to be enrolled into the pediatric Database 2 study
• Minimal or no alcohol use history consistent with NAFLD
• Having undergone a liver biopsy that is obtained within 120 days of enrollment
• Collection of biosamples (serum, plasma, DNA, and, if available, liver tissue) within 90 days prior to enrollment and 0-90 days before or 4-90 days after the standard of care liver biopsy

You may not qualify if…

• 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 (participants 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
• Cystic fibrosis
• Polycystic liver disease
• Other metabolic or congenital liver disease
• Evidence of systemic infectious disease
• Known HIV positive
• Disseminated or advanced malignancy

Where it is running

• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago (NWU) — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• St. Louis University — St Louis, Missouri, United States
• University at Buffalo-Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• Columbia University — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital- UW — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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