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
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Maastricht UMC
ACTIVE_NOT_RECRUITING
Maastricht
United Kingdom
Birmingham Children's Hospital
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Contact Information
Primary
Jake P Mann, MRCPCH
jm2032@cam.ac.uk
0044124644
Time Frame
Start Date: 2017-11-14
Estimated Completion Date: 2047-11
Participants
Target number of participants: 2000
Treatments
Non-alcoholic fatty liver disease patients
Children (\<18 years) with a diagnosis of NAFLD with radiological demonstration of increased liver fat and exclusion of other causes.
Related Therapeutic Areas
Sponsors
Collaborators: The European Association for the Study of the Liver, Children's Liver Disease Foundation
Leads: Cambridge University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov