Cohorte Des Maladies Auto-Immunes du Foie
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 13
研究概览
简要总结
The MAI-FOIE cohort will be a French multicenter cohort with the development of a biobank including patients with autoimmune, metabolic and medicated liver diseases
详细描述
The MAI-FOIE cohort will be a prospective cohort of patients with autoimmune liver diseases followed up in 13 French centers. The multicentric nature of the cohort is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to therapies. The goal is to identify different treatment response profiles, markers of remission and markers of relapse risk after discontinuation of immunosuppressants in order to improve patient care.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AIH (Auto-Immune Hepatitis) patients :
- •Inclusion Criteria :
- •age≥10 years old
- •weight≥25kg
- •AIH (with or without the presence of an overlap) whose diagnosis is validated by at least 2 of the following criteria :
- •ALT>2N or IgG>1.1N
- •Presence of autoantibodies : ANA (antinuclear), ML (anti-smooth muscle), SLA (anti-soluble liver antigen), LKM1 (anti-endoplasmic reticulum), LC1 (anti-liver cytosol)
- •Presence of interface hepatitis on biopsy
- •signing of a written consent form for participation in the study and for the storage of biological samples research
- •Control patients :
- •age≥18 years old
- •weight≥37kg
- •Patient with one of the following 3 conditions :
- •Primary Biliary Cholangitis
- •Metabolic steatohepatitis
- •Drug induced hepatitis
排除标准
- •Positive HIV serology HBV infection Positive HCV serology and PCR Patients under guardianship or curatorship
研究组 & 干预措施
AIH patients
Patients of both sexes, over 10 years old, with an established diagnosis of AIH (Auto Immune Hepatitis) will be eligible for inclusion during a medical care visit.
Control patients
Patients of both sexes, over 18 years old, with an established diagnosis of Primary Biliary Cholangitis, Metabolic Steatohepatitis or Drug-Induced Hepatitis will be eligible for inclusion during a medical care visit