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NAFLD Pediatric Database 2 — NAFLD Peds DB2  

Liver Disease Clinical Trial

Official title:
Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01061684
Study type Observational
Source Johns Hopkins Bloomberg School of Public Health
Contact
Status Completed
Phase
Start date January 20, 2010
Completion date May 31, 2020
View Details
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