A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Alanine aminotransferase (ALT) recovery
研究概览
简要总结
The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:
Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up.
详细描述
This study aims to establish a high-quality, standardized prospective cohort of AIH with regular follow-up, clarify the clinical characteristics of AIH in China, construct a prognostic model, and explore new serum markers or AIH gene susceptibility, so as to provide key clinical evidence for the prevention and treatment of AIH in China.
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
- •≥18 years old at the time of onset;
- •AIH simplified score ≥6 and/or AIH revised score ≥10;
- •Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
- •Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
- •concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
- •bone marrow or liver transplantation;
- •incomplete baseline medical history and laboratory examination results;
- •for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
- •Pregnancy or lactation;
- •patients with contraindications to glucocorticoid/immunosuppressive therapy;
- •complicated with other malignant tumors;
- •complicated with mental disorders.
结局指标
主要结局
Alanine aminotransferase (ALT) recovery
时间窗: From time of enrollment to the date of first ALT recovery, assessed up to 120 months
Normalization of ALT
Aspartate transaminase (AST) recovery
时间窗: From time of enrollment to the date of first AST recovery, assessed up to 120 months
Normalization of AST
Liver transplantaiton
时间窗: From time of enrollment to the date of liver transplantation, assessed up to 120 months
Patients have liver transplantation because of AIH
Immunoglobulin G (IgG) recovery
时间窗: From time of enrollment to the date of first IgG recovery, assessed up to 120 months
Normalization of IgG
Death
时间窗: From time of enrollment to the date of death from liver disease, assessed up to 120 months
Patients die because of liver diseases
Progression to hepatocellular carcinoma (HCC)
时间窗: From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months
Patients progress to hepatocellular carcinoma due to poor treatment response
次要结局
未报告次要终点
研究者
Zhao Xinyan
Director, Principal Investigator, Clinical Professor
Beijing Friendship Hospital