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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorCambridge University Hospitals NHS Foundation Trust

About this trial

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 criteria

Qualifiers

Diagnosis made under 18 years of age.

Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group

Sponsors and collaborators

Cambridge University Hospitals NHS Foundation Trust

Lead sponsor

The European Association for the Study of the Liver

Collaborator

Children's Liver Disease Foundation

Collaborator