NCT03190538 Nonalcoholic Steatohepatitis in Chinese Children
| NCT ID | NCT03190538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Humanity and Health Research Centre |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2017-05-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2017-05-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
George Lau, MD, PhD
PRINCIPAL INVESTIGATOR
Humanity and Health Medical Centre
Frequently Asked Questions
Who can join the NCT03190538 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03190538 currently recruiting?
Yes, NCT03190538 is actively recruiting participants. Contact the research team at gkklau@hnhmgl.com for enrollment information.
Where is the NCT03190538 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT03190538 clinical trial?
NCT03190538 is sponsored by Humanity and Health Research Centre. The principal investigator is George Lau, MD, PhD at Humanity and Health Medical Centre. The trial plans to enroll 400 participants.