Nonalcoholic Steatohepatitis in Chinese Children

Overview

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.

Full Title of Study: “Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 31, 2027

Interventions

  • Other: No intervention
    • There will be no specific intervention to these paediatric NASH patient

Clinical Trial Outcome Measures

Primary Measures

  • Liver related death
    • Time Frame: Through study completion, an average of 1 year
    • Whether the patients die from liver-related causes

Secondary Measures

  • Complications of cirrhosis
    • Time Frame: Through study completion, an average of 1 year
    • Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up
  • Liver biopsy
    • Time Frame: Through study completion, an average of 2 year
  • Liver transplant
    • Time Frame: Through study completion, an average of 1 year
    • Whether the patients have liver transplant during the follow-up

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Investigator Details

  • Lead Sponsor
    • Humanity and Health Research Centre
  • Collaborator
    • Beijing 302 Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • George Lau, MD, PhD, Principal Investigator, Humanity and Health Medical Centre
  • Overall Contact(s)
    • George Lau, MD, PhD, 852-28613777, gkklau@hnhmgl.com

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