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NCT Number: NCT03190538

Nonalcoholic Steatohepatitis in Chinese Children

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.

Recruiting

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Liver Disease Center, 302 Hospital

Beijing, China

Location status: Recruiting

Location contact

George Lau, MD

CONTACT

[email protected]

852-28613777

George Lau, MD, PhD

PRINCIPAL_INVESTIGATOR

Min Zhang, MD

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

There will be no specific intervention to these paediatric NASH patient

Primary outcomes

  1. Liver related death

    Time frame: Through study completion, an average of 1 year

    Whether the patients die from liver-related causes

Secondary outcomes

  1. 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

  2. Liver biopsy

    Time frame: Through study completion, an average of 2 year

  3. Liver transplant

    Time frame: Through study completion, an average of 1 year

    Whether the patients have liver transplant during the follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

George Lau, MD, PhD

CONTACT

[email protected]

852-28613777

Yudong Wang, MD, PhD

CONTACT

[email protected]

852-28184300

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Jun 16, 2017
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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