NAFLD Pediatric Database 2

Liver Disease Clinical Trial

— NAFLD Peds DB2  

Official title:

Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061684
• Other study ID #: NAFLD Pediatric Database 2
• Secondary ID: U01DK061730
• Status: Completed
• Start date: January 20, 2010
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 969
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University at Buffalo-Women and Children's Hospital of Buffalo	Buffalo	New York
United States	Ann & Robert H. Lurie Children's Hospital of Chicago (NWU)	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Columbia University	New York	New York
United States	St. Louis University	Saint Louis	Missouri
United States	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Seattle Children's Hospital- UW	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver histology scores	Liver histology scores (derived from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up, or liver biopsy obtained for the TONIC trial)	varies

External Links

•   Nonalcoholic Steatohepatitis Clinical Research Consortium
•   The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)