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Nonalcoholic Steatohepatitis in Chinese Children

H

Humanity and Health Research Centre

Status

Enrolling

Conditions

Non-Alcoholic Fatty Liver Disease

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03190538
H&H_ChildNASH_01

Details and patient eligibility

About

Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.

A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.

Enrollment

400 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 1-18 with biopsy-proven NAFLD
  • Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively

Exclusion criteria

  • with viral hepatitis, e.g. HBV, HCV
  • with a1-anti-trypsin disease
  • with autoimmune hepatitis
  • with Wilson disease
  • with liver impaired by drugs

Trial contacts and locations

1

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Central trial contact

Yudong Wang, MD, PhD; George Lau, MD, PhD

Data sourced from clinicaltrials.gov

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