ClinicalTrials.gg
RecruitingNCT03190538Updated Jul 29, 2026

Nonalcoholic Steatohepatitis in Chinese Children

An observational study in Non-Alcoholic Fatty Liver Disease, sponsored by Humanity and Health Research Centre. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Humanity and Health Research Centre · Observational

From the registry’s dates

  • Started May 2017; still recruiting 9 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease
03

In context

Non-alcoholic Fatty Liver Disease

1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.

This study's planned enrollment of 400 is above the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Humanity and Health Research Centre is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children with NAFLD who attended the Children's Liver Disease Center, 302 Hospital, Beijing, China will be identified and recruited. Participants met above inclusion and exclusion criteria will be invited to the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • with viral hepatitis, e.g. ,
  • with a1-anti-trypsin disease
  • with hepatitis
  • with Wilson disease
  • with liver impaired by drugs
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo intervention

    There will be no specific intervention to these paediatric NASH patient

06

What researchers measure

Primary outcomes

  1. Liver related death

    Whether the patients die from liver-related causes

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

Secondary outcomes

  1. Complications of cirrhosis

    Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up

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

  2. Liver biopsy

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

  3. Liver transplant

    Whether the patients have liver transplant during the follow-up

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

07

Study locations

1 of 1 sites recruiting
  • Children's Liver Disease Center, 302 Hospital
    Beijing, China
    Recruiting
    • George Lau, MD · Contactgkklau@hnhmgl.com · 852-28613777
    • Min Zhang, MD · Contact
    • George Lau, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03190538
Lead sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Jun 16, 2017
Start date
May 1, 2017
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Jul 29, 2026

Study contacts

George Lau, MD, PhD
Contact
gkklau@hnhmgl.com
852-28613777
Yudong Wang, MD, PhD
Contact
danny.wang@hnhmgl.com
852-28184300
George Lau, MD, PhD
principal investigator · Humanity and Health Medical Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion