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

NCT ID: NCT04190849

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2047-11-30

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver; Non-alcoholic Steatohepatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The European Association for the Study of the Liver

UNKNOWN

Sponsor Role: collaborator

Children's Liver Disease Foundation

UNKNOWN

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Jake Mann

Hepatology registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David B Savage

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Maastricht UMC

Maastricht, , Netherlands

Site Status: ACTIVE_NOT_RECRUITING

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Site Status: RECRUITING

Birmingham Children's Hospital

Birmingham, , United Kingdom

Site Status: RECRUITING

Countries

Netherlands; United Kingdom

Central Contacts

Jake P Mann, MRCPCH

Role: CONTACT

jm2032@cam.ac.uk

0044124644

Facility Contacts

Jake P Mann

Role: primary

jm2032@cam.ac.uk

00447804124644

Indra van Mourik

Role: primary

References

Mann 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.

Reference Type: BACKGROUND

PMID: 30408605 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

174534

Identifier Type: OTHER

Identifier Source: secondary_id

A094204

Identifier Type: -

Identifier Source: org_study_id