NCT04190849 European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)
| NCT ID | NCT04190849 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2017-11-14 |
| Primary Completion | 2047-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2017-11-14 with a primary completion date of 2047-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
David B Savage
PRINCIPAL INVESTIGATOR
University of Cambridge
Frequently Asked Questions
Who can join the NCT04190849 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04190849 currently recruiting?
Yes, NCT04190849 is actively recruiting participants. Contact the research team at jm2032@cam.ac.uk for enrollment information.
Where is the NCT04190849 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Cambridge, United Kingdom, Birmingham, United Kingdom.
Who is sponsoring the NCT04190849 clinical trial?
NCT04190849 is sponsored by Cambridge University Hospitals NHS Foundation Trust. The principal investigator is David B Savage at University of Cambridge. The trial plans to enroll 2,000 participants.