Nonalcoholic Steatohepatitis in Chinese Children
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 10, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
March 24, 2025
March 1, 2025
10.1 years
June 10, 2017
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Liver related death
Whether the patients die from liver-related causes
Through study completion, an average of 1 year
Secondary Outcomes (3)
Complications of cirrhosis
Through study completion, an average of 1 year
Liver biopsy
Through study completion, an average of 2 year
Liver transplant
Through study completion, an average of 1 year
Interventions
There will be no specific intervention to these paediatric NASH patient
Eligibility Criteria
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.
You may qualify if:
- age 1-18 with biopsy-proven NAFLD
- Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively
You may not qualify if:
- with viral hepatitis, e.g. HBV, HCV
- with a1-anti-trypsin disease
- with autoimmune hepatitis
- with Wilson disease
- with liver impaired by drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Humanity and Health Research Centrelead
- Beijing 302 Hospitalcollaborator
Study Sites (1)
Children's Liver Disease Center, 302 Hospital
Beijing, China
Biospecimen
Liver-biopsy will be collected and to be used as the diagnosis of NASH.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Lau, MD, PhD
Humanity and Health Medical Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2017
First Posted
June 16, 2017
Study Start
May 1, 2017
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2028
Last Updated
March 24, 2025
Record last verified: 2025-03