Is Negativity of Autoantibodies a Marker of Severity in Auto-immune Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- histological rereading of seronegative AIH
研究概览
简要总结
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.
详细描述
Evaluate the proportion of seronegative auto-immune hepatitis and a possible relationship with the severity of the disease. Criteria of severity will be defined by corticodependance, corticoresistance and a severe form of the disease at diagnosis (cirrhosis or fulminant hepatitis). In case of predominant seronegative forms, other auto-antibodies related to this auto-immue hepatitis will be searched.
Patients from the Guadeloupean constitutive center of rare diseases (CCRD Filfoie) and from the Saint-Antoine hospital will be retrospectively analyzed, and new patients will be prospectively followed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Any patient over 18 years old
- •Patient followed at Hôpital Saint-Antoine or treated for HAI or in Guadeloupe within the framework of the CCRD Filfoie for an acute or chronic AIH under immunosuppressive treatment
- •Patient affiliate or beneficiary of a social security scheme
- •Free, informed and written consent signed by the patient and the investigator
- •o exclusion criteria: - Patient under 18 years old
- •Patient not able to give his/her consent
- •Viral hepatitis: viruses A to E, Epstein-Barr virus, cytomegalovirus and herpes simplex virus
- •Isolated primary biliary cholangitis
- •Isolated primary sclerosing cholangitis
- •Drug-induced liver injury
- •Wilson disease
- •Alcoholic hepatitis
- •Hemochromatosis
- •Sickle cell disease and heart liver
- •Non-alcoholic steato-hepatitis
排除标准
- 未提供
结局指标
主要结局
histological rereading of seronegative AIH
时间窗: Baseline
Percentage comparisons will be made by a chi-2 test or a Fischer test.
次要结局
- assessment of the severity of the disease(6 months, 12 months)
- Constitution of a serotheque in order to search for other autoAb described as correlated to the severity of the AIH.(At inclusion)