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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04190849
Other study ID # A094204
Secondary ID 174534
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2017
Est. completion date November 2047

Study information

Verified date February 2022
Source Cambridge University Hospitals NHS Foundation Trust
Contact Jake P Mann, MRCPCH
Phone 0044124644
Email jm2032@cam.ac.uk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date November 2047
Est. primary completion date November 2047
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Maastricht UMC Maastricht
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Addenbrooke's Hospital Cambridge Cambridgeshire

Sponsors (3)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust Children's Liver Disease Foundation, The European Association for the Study of the Liver

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival All-cause survival 30-year follow-up
Secondary Cardiovascular morbidity CAD, CVA, PAD 30-year follow-up
Secondary Liver morbidity Decompensated liver disease, transplantation, HCC development 30-year follow-up
Secondary Asymptomatic progression of liver disease Presence of advanced fibrosis (on biopsy or non-invasive imaging) 30-year follow-up
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