Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-alcoholic Fatty Liver | — | UNRESOLVED | — |
| Non-Alcoholic Fatty Liver Disease | — | UNRESOLVED | — |
| Non-alcoholic Steatohepatitis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Non-alcoholic fatty liver disease patients
- description
- Children (\<18 years) with a diagnosis of NAFLD with radiological demonstration of increased liver fat and exclusion of other causes.
Primary outcomes (1)
- measure
- Survival
- timeFrame
- 30-year follow-up
- description
- All-cause survival
Secondary outcomes (3)
- measure
- Cardiovascular morbidity
- timeFrame
- 30-year follow-up
- description
- CAD, CVA, PAD
- measure
- Liver morbidity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDMann JP, Vreugdenhil A, Socha P, Janczyk W, Baumann U, Rajwal S, Casswall T, Marcus C, van Mourik I, O'Rahilly S, Savage DB, Noble-Jamieson G, Lacaille F, Dabbas M, Dubern B, Kelly DA, Nobili V, Anstee QM. European paediatric non-alcoholic fatty liver disease registry (EU-PNAFLD): Design and rationale. Contemp Clin Trials. 2018 Dec;75:67-71. doi: 10.1016/j.cct.2018.11.003. Epub 2018 Nov 5. PMID 30408605