Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

Status: Completed
Location: See all (12) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: No
View:

• 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

Locations
United States
California
University of California, San Diego
San Diego
University of California, San Francisco
San Francisco
Georgia
Emory University
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago (NWU)
Chicago
Indiana
Riley Hospital for Children
Indianapolis
Maryland
Johns Hopkins University
Baltimore
Missouri
St. Louis University
Saint Louis
New York
University at Buffalo-Women and Children's Hospital of Buffalo
Buffalo
Columbia University
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Texas
Texas Children's Hospital
Houston
Washington
Seattle Children's Hospital- UW
Seattle
Time Frame
Start Date: January 20, 2010
Completion Date: May 31, 2020
Participants
Target number of participants: 969
Treatments
NAFLD
pediatric patients with non-alcoholic fatty liver disease (NAFLD).
Authors
Adjay Jain, Ajay Jain, Mark Fishbein, Joel Lavine, Stephanie Abrams, Susan Baker, Jeffrey Schwimmer, Paula Hertel, Saul Karpen, Karen Murray, Stavra Xanthakos, Philip Rosenthal, Tamir Miloh, Jean Molleston, Peter Whittington
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins Bloomberg School of Public Health
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov

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