Clinical trial NCT05785793: Autoimmune Hepatitis Cohort in China
Official title: Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Hepatitis
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The patients diagnosed as AIH in medical centers and outpatient clinics.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Transplant free survival
timeFrame: From baseline to 60 months after baseline
Secondary outcomes:
measure: Liver-related death
timeFrame: From baseline to 60 months after baseline
measure: Biochemical response
timeFrame: From baseline to 60 months after baseline
measure: Remission
timeFrame: From baseline to 60 months after baseline
measure: Complications
timeFrame: From baseline to 60 months after baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Xiong Ma, MD,PHD
role: STUDY_CHAIR
References: