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Nonalcoholic Steatohepatitis in Chinese Children

Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03190538
Enrollment
400
Registered
2017-06-16
Start date
2017-05-01
Completion date
2028-05-31
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Brief summary

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.

Interventions

OTHERNo intervention

There will be no specific intervention to these paediatric NASH patient

Sponsors

Humanity and Health Research Centre
Lead SponsorOTHER
Beijing 302 Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Liver related deathThrough study completion, an average of 1 yearWhether the patients die from liver-related causes

Secondary

MeasureTime frameDescription
Complications of cirrhosisThrough study completion, an average of 1 yearWhether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up
Liver biopsyThrough study completion, an average of 2 year
Liver transplantThrough study completion, an average of 1 yearWhether the patients have liver transplant during the follow-up

Countries

China

Contacts

CONTACTGeorge Lau, MD, PhD
gkklau@hnhmgl.com852-28613777
CONTACTYudong Wang, MD, PhD
danny.wang@hnhmgl.com852-28184300
PRINCIPAL_INVESTIGATORGeorge Lau, MD, PhD

Humanity and Health Medical Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026