NAFLD Pediatric Database 2 (NAFLD Peds DB2)

This study is currently recruiting participants.
Verified October 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01061684
First received: February 2, 2010
Last updated: October 17, 2013
Last verified: October 2013

February 2, 2010
October 17, 2013
December 2009
January 2015   (final data collection date for primary outcome measure)
Liver histology scores [ Time Frame: varies ] [ Designated as safety issue: No ]
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)
Not Provided
Complete list of historical versions of study NCT01061684 on ClinicalTrials.gov Archive Site
Not Provided
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NAFLD Pediatric Database 2
Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database 2

The NAFLD Database 2 will recruit at least 250 new pediatric participants and will also invite pediatric participants from the prior NAFLD Database and TONIC trial 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 300 pediatric participants with liver biopsies and contemporaneous biosamples during the 18 month enrollment period.

An estimated additional 150 pediatric participants continuing from the NAFLD Database study and TONIC trial will also be enrolled, but without a contemporaneous liver biopsy at the time of enrollment.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

plasma, serum, liver tissue

Non-Probability Sample

Participants at least 2 years of age and less than 18 years of age with known or suspected NAFLD or NASH-related cirrhosis

Liver Disease
Not Provided
NAFLD
pediatric patients with non-alcoholic fatty liver disease (NAFLD).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
December 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Not Provided
United States
 
NCT01061684
NAFLD Pediatric Database 2
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Study Director: Ed Doo, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP