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A Study on Factors of Biochemical Response in Autoimmune Hepatitis

ConditionAutoimmune Hepatitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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;

Disqualifiers

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;

Trial population

AIH patients who fulfilled the inclusion and exclusion criteria were enrolled in this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

630 Participants
are grouped into 2 trial groups
Group A: Modeling group
Group B: Validation group

Trial outcomes

Primary outcomes

1

Alanine aminotransferase (ALT) recovery

Normalization of ALT

Time frame
From time of enrollment to the date of first ALT recovery, assessed up to 120 months
2

Aspartate transaminase (AST) recovery

Normalization of AST

Time frame
From time of enrollment to the date of first AST recovery, assessed up to 120 months
3

Immunoglobulin G (IgG) recovery

Normalization of IgG

Time frame
From time of enrollment to the date of first IgG recovery, assessed up to 120 months
4

Death

Patients die because of liver diseases

Time frame
From time of enrollment to the date of death from liver disease, assessed up to 120 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: