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Summary

for people ages 2–17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

Details

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.

Keywords

Liver Disease fatty liver disease NASH NAFLD non-alcoholic steatohepatitis

Eligibility

You can join if…

Open to people ages 2–17

  • 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 CAN'T join 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
  • 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

Locations

  • University of California, San Diego accepting new patients
    San Diego, California, 92103, United States
  • Seattle Children's Hospital- UW accepting new patients
    Seattle, Washington, 98105, United States
  • Texas Children's Hospital accepting new patients
    Houston, Texas, 77030, United States
  • St. Louis University accepting new patients
    St. Louis, Missouri, 63104, United States
  • Children's Memorial Hospital (NWU) accepting new patients
    Chicago, Illinois, 60614, United States
  • Riley Hospital for Children accepting new patients
    Indianapolis, Indiana, 46202, United States
  • Cincinnati Children's Hospital Medical Center accepting new patients
    Cincinnati, Ohio, 45229-3039, United States
  • Emory University accepting new patients
    Atlanta, Georgia, 30322, United States
  • University at Buffalo-Women and Children's Hospital of Buffalo accepting new patients
    Buffalo, New York, 14222, United States
  • Johns Hopkins University in progress, not accepting new patients
    Baltimore, Maryland, 21205, United States
  • Columbia University accepting new patients
    New York, New York, 10032, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Links
Nonalcoholic Steatohepatitis Clinical Research Consortium
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ID
NCT01061684
Lead Scientist
Philip Rosenthal
Study Type
Observational
Last Updated
March 1, 2017
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