European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)

NCT04190849 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Phase

Observational

Started

2017-11-14

Last updated

2022-03-04

Condition(s) studied

Non-Alcoholic Fatty Liver DiseaseNon-alcoholic Fatty LiverNon-alcoholic Steatohepatitis

Study summary

The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry ("EPoS", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.

Eligibility

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

Inclusion Criteria: * Diagnosis made under 18 years of age. * Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis) * Diagnosis established by: * Radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with * Exclusion of secondary causes (negative serological liver screen for HBV/HCV, caeruloplasmin \>0.20g/L, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (A1AT) phenotype (i.e. SZ, ZZ, SS), with or without * Histology (\>5% steatosis and histology consistent with paediatric NAFLD) Exclusion Criteria: * Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus) * Post-transplant fatty liver * \>20g/day ethanol intake

Primary outcome measure(s)

Survival — 30-year follow-up
All-cause survival

Trial sites (3)

Facility	City	Region	Status
Maastricht UMC	Maastricht	Netherlands	Active Not Recruiting
Addenbrooke's Hospital	Cambridge	Cambridgeshire	Recruiting
Birmingham Children's Hospital	Birmingham	United Kingdom	Recruiting

Other trials for the same condition

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) Active, not recruiting

Effect of Timed-Restricted Eating on Metabolic Health Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04190849 on ClinicalTrials.gov ↗ ← All trials in the Netherlands