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临床试验/NCT03190538
NCT03190538招募中不适用

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

Humanity and Health Research Centre1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Liver related death

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 1-18 with biopsy-proven NAFLD
  • Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively

排除标准

  • with viral hepatitis, e.g. HBV, HCV
  • with a1-anti-trypsin disease
  • with autoimmune hepatitis
  • with Wilson disease
  • with liver impaired by drugs

结局指标

主要结局

Liver related death

时间窗: Through study completion, an average of 1 year

Whether the patients die from liver-related causes

次要结局

  • Liver transplant(Through study completion, an average of 1 year)
  • Complications of cirrhosis(Through study completion, an average of 1 year)
  • Liver biopsy(Through study completion, an average of 2 year)

研究者

发起方
Humanity and Health Research Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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