NAFLD Pediatric Database 2



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:2 - 17
Updated:3/15/2019
Start Date:January 20, 2010
End Date:December 31, 2019

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Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

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.

All the new pediatric participants will have had a liver biopsy within 120 days prior to
enrollment coupled with contemporaneous biosamples within 90 days prior to enrollment and up
to 90 days before or 4-90 days after the biopsy. We estimate that at least 50 of the
continuing pediatric participants will be due for a standard of care liver biopsy at the time
of their enrollment into the pediatric Database 2 study, and will, as a result, also have a
liver biopsy and contemporaneous biosamples.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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 for parent to provide informed consent and child 8 years or greater to give
assent
We found this trial at
12
sites
San Francisco, California 94143
Principal Investigator: Philip Rosenthal, MD
Phone: 415-476-1756
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Saul Karpen, MD
Phone: 404-727-5383
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Stavra Xanthakos, MD
Phone: 513-636-4406
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Joel Lavine, MD, PhD
Phone: 212-305-6274
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Buffalo, New York 14222
Phone: 716-878-7391
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Chicago, Illinois 60611
Principal Investigator: Mark Fishbein, MD
Phone: 312-227-4559
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Tamir Miloh, MD
Phone: 832-824-3848
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Jean Molleston, MD
Phone: 317-944-4490
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Saint Louis, Missouri 63110
Phone: 314-977-9400
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San Diego, California 92093
Principal Investigator: Jeffrey Schwimmer, MD
Phone: 619-543-5226
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Seattle, Washington 98105
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