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Nonalcoholic Steatohepatitis in Chinese Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03190538
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Beijing 302 Hospital
Information provided by (Responsible Party):
Humanity and Health Research Centre

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.

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Other: No intervention

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : May 31, 2028

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

Primary Outcome Measures :
  1. Liver related death [ Time Frame: Through study completion, an average of 1 year ]
    Whether the patients die from liver-related causes

Secondary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Liver-biopsy will be collected and to be used as the diagnosis of NASH.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03190538

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Contact: George Lau, MD, PhD 852-28613777
Contact: Yudong Wang, MD, PhD 852-28184300

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Children's Liver Disease Center, 302 Hospital Recruiting
Beijing, China
Contact: George Lau, MD    852-28613777   
Contact: Min Zhang, MD         
Principal Investigator: George Lau, MD, PhD         
Sponsors and Collaborators
Humanity and Health Research Centre
Beijing 302 Hospital
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Principal Investigator: George Lau, MD, PhD Humanity and Health Medical Centre

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Responsible Party: Humanity and Health Research Centre Identifier: NCT03190538     History of Changes
Other Study ID Numbers: H&H_ChildNASH_01
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases