Registry for children with Non-Alcoholic Fatty Liver Disease in Europe
The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease
This study is creating a large registry to help doctors learn more about Non-Alcoholic Fatty Liver Disease in children and improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 3 sites (Maastricht and 2 other locations) |
| Trial ID | NCT04190849 on ClinicalTrials.gov |
What this trial studies
The EU-PNAFLD is a collaborative network of European centers focused on the care of children diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD). This observational registry aims to create a large-scale cohort that will facilitate multi-center clinical trials and enhance understanding of the disease mechanisms and natural history of pediatric NAFLD. It will leverage existing databases and bio-repositories while aligning with the adult European NAFLD Registry for comprehensive long-term follow-up. The collaboration includes hepatologists, endocrinologists, and scientists, supported by international specialists.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years diagnosed with the NAFLD spectrum, including simple steatosis and non-alcoholic steatohepatitis.
Not a fit: Patients with secondary fatty liver diseases or those with significant alcohol intake will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to improved understanding and management of pediatric NAFLD, ultimately enhancing patient outcomes.
How similar studies have performed: Other studies have shown success with similar registry approaches in understanding liver diseases, indicating potential for this initiative.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maastricht and 2 other locations
- Maastricht UMC — Maastricht, Netherlands (Active_not_recruiting)
- Addenbrooke's Hospital — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
- Birmingham Children's Hospital — Birmingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David B Savage — University of Cambridge
- Study coordinator: Jake P Mann, MRCPCH
- Email: jm2032@cam.ac.uk
- Phone: 0044124644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.