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NCT Number: NCT06356506

A Study on Factors of Biochemical Response in Autoimmune Hepatitis

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.

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Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Digestive System Diseases Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Alanine aminotransferase (ALT) recovery

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

    Normalization of ALT

  2. Aspartate transaminase (AST) recovery

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

    Normalization of AST

  3. Immunoglobulin G (IgG) recovery

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

    Normalization of IgG

  4. Death

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

    Patients die because of liver diseases

  5. Liver transplantaiton

    Time frame: From time of enrollment to the date of liver transplantation, assessed up to 120 months

    Patients have liver transplantation because of AIH

  6. Progression to hepatocellular carcinoma (HCC)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Qianyi Wang

CONTACT

[email protected]

18519667363

Yu Su

CONTACT

[email protected]

18810639513

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Apr 10, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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