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临床试验/NCT06020976
NCT06020976尚未招募不适用

Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital

Sohag University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
liver biobsy

研究概览

简要总结

Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology. If left untreated, it progresses to liver cirrhosis and liver failure.

Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of positive clinical, biochemical, and histological criteria.

AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an acute severe fulminant disease.

It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes, vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.

Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.

Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where interface hepatitis is the hallmark of the disease.

Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the initial therapy either alone or in combination with azathioprine.

Liver transplantation is indicated in patients who develop fulminant hepatic failure that is unresponsive to corticosteroids and in patients who develop end-stage liver disease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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: under 18 years old.
  • Both sex.
  • children suffering from manifestations of Autoimmune Hepatitis. Children previously Diagnosed with Autoimmune Hepatitis

排除标准

  • Patient infected with hepatitis B or C.
  • Patient had autoimmune hepatitis after liver transplantation.
  • Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute and chronich hepatitis like wilson disease and Metabolic liver Diseases

结局指标

主要结局

liver biobsy

时间窗: 1 year

to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation

autoantibody

时间窗: 1 year

Autoantibodies will be considered positive and clinically significant when present at a dilution ≥1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or ≥1:10 for liver kidney microsomal (anti-LKM-1).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fathy Mohamed Abdelhakam

Resident-pediatric department-sohag hospital university

Sohag University

研究点 (1)

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