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Liver DiseaseNAFLD Peds DB2NCT01061684

NAFLD Pediatric Database 2

An observational study of Liver Disease, run by Johns Hopkins Bloomberg School of Public Health at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Liver Disease
How many people
969 participants
Where
12 sitesUnited States
Study dates
20 Jan 2010to 31 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University at Buffalo-Women and Children's Hospital of Buffalo

    Buffalo, New York, 14222

  • Ann & Robert H. Lurie Children's Hospital of Chicago (NWU)

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Columbia University

    New York, New York, 10032

  • University of California, San Diego

    San Diego, California, 92103

  • University of California, San Francisco

    San Francisco, California, 94143

  • Seattle Children's Hospital- UW

    Seattle, Washington, 98105

  • St. Louis University

    St Louis, Missouri, 63104

Other trials in United States

About this study

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

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.

Read the 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
Keywords
fatty liver disease, NASH, NAFLD, non-alcoholic steatohepatitis
Medical subject headings
Liver Diseases, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01061684
Study groupRoleWhat they receive
NAFLDpediatric patients with non-alcoholic fatty liver disease (NAFLD).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: varies

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study start20 Jan 2010
  3. Primary completion31 May 2020
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
969 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061684
Sponsor's protocol ID
NAFLD Pediatric Database 2
Other IDs
U01DK061730
Acronym
NAFLD Peds DB2
Status last verified
Feb 2022
First submitted
2 Feb 2010
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data will be uploaded to www.niddkrepository.org at the end of the funding.

Publications

  • Hang Nghiem-Rao T, Johnson JS, Pan A, Atkinson SN, Behling C, Simpson PM, Holtz ML, Weinstock GM, Schwimmer JB, Salzman NH. A serum-induced gene signature in hepatocytes is associated with pediatric nonalcoholic fatty liver disease. J Pediatr Gastroenterol Nutr. 2024 Apr;78(4):886-897. doi: 10.1002/jpn3.12163. Epub 2024 Feb 23.

    PubMed 38390691

  • Rausch JC, Lavine JE, Chalasani N, Guo X, Kwon S, Schwimmer JB, Molleston JP, Loomba R, Brunt EM, Chen YI, Goodarzi MO, Taylor KD, Yates KP, Rotter JI; NASH Clinical Research Network. Genetic Variants Associated With Obesity and Insulin Resistance in Hispanic Boys With Nonalcoholic Fatty Liver Disease. J Pediatr Gastroenterol Nutr. 2018 May;66(5):789-796. doi: 10.1097/MPG.0000000000001926.

    PubMed 29470286

  • Molleston JP, Schwimmer JB, Yates KP, Murray KF, Cummings OW, Lavine JE, Brunt EM, Scheimann AO, Unalp-Arida A; NASH Clinical Research Network. Histological abnormalities in children with nonalcoholic fatty liver disease and normal or mildly elevated alanine aminotransferase levels. J Pediatr. 2014 Apr;164(4):707-713.e3. doi: 10.1016/j.jpeds.2013.10.071. Epub 2013 Dec 19.

    PubMed 24360992

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Disease, run by Johns Hopkins Bloomberg School of Public Health at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver histology scores (time frame: varies). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061684, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.

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