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
This trial does not accept healthy volunteersQualifiers
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 population
Children with NAFLD who have been diagnosed either invasively (i.e. using liver biopsy) or using some form of imaging (USS, MRI, CT, MRS) plus exclusion of secondary causes using an appropriate panel of bloods. This aims to facilitate recruitment from a representative population of children, not just those from specialist centres who have undergone biopsy. 'Secondary NAFLD' (i.e. drug-induced, post-transplant) are not eligible. Children with insulin resistance syndromes are not specifically excluded however this is not the primary focus of EU-PNAFLD and other condition-specific registries are in existence.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: Non-alcoholic fatty liver disease patients
Trial outcomes
Primary outcomes
1
Survival
All-cause survival
Time frame
30-year follow-upSecondary outcomes
1
Cardiovascular morbidity
CAD, CVA, PAD
Time frame
30-year follow-up2
Liver morbidity
Decompensated liver disease, transplantation, HCC development
Time frame
30-year follow-up3
Asymptomatic progression of liver disease
Presence of advanced fibrosis (on biopsy or non-invasive imaging)
Time frame
30-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cambridge University Hospitals NHS Foundation Trust
Lead sponsor
The European Association for the Study of the Liver
Collaborator
Children's Liver Disease Foundation
Collaborator
Source ClinicalTrials.gov