Nonalcoholic Fatty Liver Disease (NAFLD) Database 3

Status: Active_not_recruiting
Location: See all (16) locations...
Study Type: Observational
SUMMARY

The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 2 years of age or older as of the initial screening interview and provision of consent

• Willingness to participate in the study for 1 or more years

• Histologic evidence of NAFLD or NASH based upon a standard of care liver biopsy

• Collection of serum and plasma up to 90 days before or 4- 90 days after standard of care liver biopsy

• Absence of regular or excessive use of alcohol within 2 years prior to initial screening

Locations
United States
California
University of California, San Diego- Adults
La Jolla
University of Southern California
Los Angeles
University of California, San Diego Pediatrics
San Diego
University of California, San Francisco
San Francisco
Georgia
Emory University-Pediatrics
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Indiana
Indiana University- Adults
Indianapolis
Riley Hospital for Children
Indianapolis
Missouri
St. Louis University
Saint Louis
North Carolina
Duke University Medical Center
Durham
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Cleveland Clinic Foundation
Cleveland
Texas
Texas Children's Hospital, Baylor University
Houston
Virginia
Virginia Commonwealth University
Richmond
Washington
Liver Institute Northwest
Seattle
Seattle Children's Hospital- SEA
Seattle
Time Frame
Start Date: 2020-11-13
Completion Date: 2025-06-30
Participants
Target number of participants: 1640
Treatments
Adult patients with NAFLD
1500 patients 18 years and older at the time of enrollment.
Pediatric patients with NAFLD
750 patients 2 years or older and up to 17 years old at the time of enrollment.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, University of Southern California, University of California, San Diego, Emory University, Seattle Children's Hospital, Children's Hospital Medical Center, Cincinnati, St. Louis University, Duke University, Case Western Reserve University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Virginia Commonwealth University, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Liver Institute Northwest, University of California, San Francisco
Leads: Johns Hopkins Bloomberg School of Public Health

This content was sourced from clinicaltrials.gov