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

The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04190849

Acronym

EU-PNAFLD

Enrollment

2000

Registered

2019-12-09

Start date

2017-11-14

Completion date

2047-11-30

Last updated

2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis

Keywords

Cirrhosis, Liver disease, Hepatocellular carcinoma, Type 2 diabetes, Atherosclerosis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 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

Design outcomes

Primary

Measure	Time frame	Description
Survival	30-year follow-up	All-cause survival

Secondary

Measure	Time frame	Description
Cardiovascular morbidity	30-year follow-up	CAD, CVA, PAD
Liver morbidity	30-year follow-up	Decompensated liver disease, transplantation, HCC development
Asymptomatic progression of liver disease	30-year follow-up	Presence of advanced fibrosis (on biopsy or non-invasive imaging)

Countries

Netherlands, United Kingdom

Contacts

Primary ContactJake P Mann, MRCPCH

jm2032@cam.ac.uk0044124644

Outcome results