Nonalcoholic Steatohepatitis in Chinese Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: George Lau, MD, PhD; Phone Number: 852-28613777; Email: gkklau@hnhmgl.com
• Study Contact Backup: Name: Yudong Wang, MD, PhD; Phone Number: 852-28184300; Email: danny.wang@hnhmgl.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Children's Liver Disease Center, 302 Hospital
    • Contact: George Lau, MD; Phone Number: 852-28613777; Email: gkklau@hnhmgl.com
    • Contact: Min Zhang, MD
    • Principal Investigator: George Lau, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver related death	Whether the patients die from liver-related causes	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Liver biopsy		Through study completion, an average of 2 year
Liver transplant	Whether the patients have liver transplant during the follow-up	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Humanity and Health Research Centre
• Collaborators: Beijing 302 Hospital
• Investigators: Principal Investigator: George Lau, MD, PhD, Humanity and Health Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): May 31, 2027
• Study Completion (Anticipated): May 31, 2028

Study Registration Dates

• First Submitted: June 10, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: H&H_ChildNASH_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No