A Study on Factors of Biochemical Response in Autoimmune Hepatitis

Autoimmune Hepatitis Clinical Trial

Official title:

A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356506
• Other study ID #: 2022-P2-338-01
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: May 1, 2034

Study information

• Verified date: April 2024
• Source: Beijing Friendship Hospital
• Contact: Yu Su
• Phone: 18810639513
• Email: suyu_7912[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 630
• Est. completion date: May 1, 2034
• Est. primary completion date: May 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alanine aminotransferase (ALT) recovery	Normalization of ALT	From time of enrollment to the date of first ALT recovery, assessed up to 120 months
Primary	Aspartate transaminase (AST) recovery	Normalization of AST	From time of enrollment to the date of first AST recovery, assessed up to 120 months
Primary	Immunoglobulin G (IgG) recovery	Normalization of IgG	From time of enrollment to the date of first IgG recovery, assessed up to 120 months
Primary	Death	Patients die because of liver diseases	From time of enrollment to the date of death from liver disease, assessed up to 120 months
Primary	Liver transplantaiton	Patients have liver transplantation because of AIH	From time of enrollment to the date of liver transplantation, assessed up to 120 months
Primary	Progression to hepatocellular carcinoma (HCC)	Patients progress to hepatocellular carcinoma due to poor treatment response	From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months