Health TrialsbyHealthPanel

Nonalcoholic Steatohepatitis in Chinese Children

ConditionNon-Alcoholic Fatty Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorHumanity and Health Research Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 1-18 with biopsy-proven NAFLD

Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively

Disqualifiers

with viral hepatitis, e.g. HBV, HCV

with a1-anti-trypsin disease

with autoimmune hepatitis

with Wilson disease

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    There will be no specific intervention to these paediatric NASH patient

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Humanity and Health Research Centre

Lead sponsor

Beijing 302 Hospital

Collaborator

Source ClinicalTrials.gov
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