Nonalcoholic Steatohepatitis in Chinese Children

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190538
• Other study ID #: H&H_ChildNASH_01
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: May 31, 2028

Study information

• Verified date: August 2021
• Source: Humanity and Health Research Centre
• Contact: George Lau, MD, PhD
• Phone: 852-28613777
• Email: gkklau[@]hnhmgl.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2027
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
China	Children's Liver Disease Center, 302 Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver related death	Whether the patients die from liver-related causes	Through study completion, an average of 1 year
Secondary	Complications of cirrhosis	Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up	Through study completion, an average of 1 year
Secondary	Liver biopsy		Through study completion, an average of 2 year
Secondary	Liver transplant	Whether the patients have liver transplant during the follow-up	Through study completion, an average of 1 year