NCT01061684

NAFLD Pediatric Database 2

Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 969 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Liver Disease

Timeline

• Start date: 2010-01-20
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2010-02-03
• Last updated: 2022-02-23

Locations

12 sites across 1 country: United States