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NCT Number: NCT05785793

Autoimmune Hepatitis Cohort in China

The goal of this observational study is to describe the clinical features and long-term prognosis in patients diagnosed with autoimmune hepatitis (AIH) in China and assess the effectiveness and safety of AIH treatment options in a real-world setting.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200001, China

Location status: Recruiting

Location contact

Xiao Xiao

CONTACT

[email protected]

021-68383104

About this study

Autoimmune hepatitis (AIH) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. Although relatively rare, the prevalence of AIH in China has been increasing in recent years, highlighting its significance as a public health issue. However, due to the wide variability in the clinical presentation and outcomes of AIH, diagnosing and managing the disease can be challenging. Moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of AIH in China is still limited.

To address this gap in knowledge, the investigators are conducting the Chinese AIH Cohort study, which collects data from approximately 20 sites across China on treatment progress and success in clinical routine. The study aims to evaluate the effectiveness and safety/tolerability of different AIH treatment options, including standard therapy, and second and third-line treatment options. The investigators also record the long-term prognosis of patients with AIH, tracking whether they achieve remission, require liver transplantation, or experience mortality. Risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of AIH in this population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 14 years
  • Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria
  • Availability of all following essential parameters at the initial diagnosis of AIH: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count
  • Provide informed consent

Exclusion criteria

  • Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin G 4-related cholangitis
  • Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus
  • Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of AIH
  • Considered ineligible to the enrollment in the clinical study by the researcher

Treatment and study plan

Primary outcomes

  1. Transplant free survival

    Time frame: From baseline to 60 months after baseline

    Time to the first occurrence of liver transplant or death from any cause

Secondary outcomes

  1. Liver-related death

    Time frame: From baseline to 60 months after baseline

    Time to the first occurrence of liver transplant or death from liver-related cause

  2. Biochemical response

    Time frame: From baseline to 60 months after baseline

    Proportion of patients who achieve complete biochemical response (normalisation of serum transaminases and immunoglobulin G below the ULN)

  3. Remission

    Time frame: From baseline to 60 months after baseline

    Proportion of patients who achieve remission (hepatitis activity index<4/18)

  4. Complications

    Time frame: From baseline to 60 months after baseline

    Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma

Study contacts

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

Xiao Xiao, MD

CONTACT

[email protected]

021-68383104

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China

Acronym: CAMERA

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2023
Registry last updated
Mar 28, 2023

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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