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NCT Number: NCT04190849

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Adenocarcinoma Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Carcinoma Carcinoma, Hepatocellular Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Fatty Liver Fibrosis Glucose Metabolism Disorders Liver Diseases Liver Neoplasms Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-alcoholic Fatty Liver Non-alcoholic Steatohepatitis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht UMC, Maastricht, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: 30-year follow-up

    All-cause survival

Secondary outcomes

  1. Cardiovascular morbidity

    Time frame: 30-year follow-up

    CAD, CVA, PAD

  2. Liver morbidity

    Time frame: 30-year follow-up

    Decompensated liver disease, transplantation, HCC development

  3. Asymptomatic progression of liver disease

    Time frame: 30-year follow-up

    Presence of advanced fibrosis (on biopsy or non-invasive imaging)

Study contacts

Contact information is provided by the study sponsor or research team.

Jake P Mann, MRCPCH

CONTACT

[email protected]

0044124644

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • Children's Liver Disease Foundation
  • The European Association for the Study of the Liver

Registry information

Official study title

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

Acronym: EU-PNAFLD

Important dates

Study start
2017
Primary completion
2047
Study completion
2047
First posted
Dec 9, 2019
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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