Clinical trial NCT06356506: A Study on Factors of Biochemical Response in Autoimmune Hepatitis
Official title: A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Hepatitis
Keywords: Autoimmune hepatitis
Biochemical response
Prognosis
Immunosuppressive therapy
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AIH patients who fulfilled the inclusion and exclusion criteria were enrolled in this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old at the time of onset;
2. AIH simplified score ≥6 and/or AIH revised score ≥10;
3. Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
4. Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
5. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
2. concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
3. bone marrow or liver transplantation;
4. incomplete baseline medical history and laboratory examination results;
5. for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
6. Pregnancy or lactation;
7. patients with contraindications to glucocorticoid/immunosuppressive therapy;
8. complicated with other malignant tumors;
9. complicated with mental disorders.

Primary outcomes:
measure: Alanine aminotransferase (ALT) recovery
timeFrame: From time of enrollment to the date of first ALT recovery, assessed up to 120 months
measure: Aspartate transaminase (AST) recovery
timeFrame: From time of enrollment to the date of first AST recovery, assessed up to 120 months
measure: Immunoglobulin G (IgG) recovery
timeFrame: From time of enrollment to the date of first IgG recovery, assessed up to 120 months
measure: Death
timeFrame: From time of enrollment to the date of death from liver disease, assessed up to 120 months
measure: Liver transplantaiton
timeFrame: From time of enrollment to the date of liver transplantation, assessed up to 120 months
measure: Progression to hepatocellular carcinoma (HCC)
timeFrame: From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Xinyan Zhao
role: STUDY_CHAIR
affiliation: Beijing 302 Hospital
name: Zhengsheng Zou
role: STUDY_CHAIR
affiliation: Beijing You 'an Hospital, Capital Medical University
name: Yu Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Second People's Hospital
name: Jia Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Xiamen University
name: Jingshou Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Lanzhou University Second Hospital
name: Liang Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiaozuo People's Hospital
name: Huahua Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Heilongjiang Provincinal Hospital
name: Xiaoli Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: Qinghai People's Hospital
name: Pingying Li
role: PRINCIPAL_INVESTIGATOR
References: