Autoimmune Hepatitis Cohort in China

Autoimmune Hepatitis Clinical Trial

— CAMERA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785793
• Other study ID #: AIH-CH
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: February 1, 2028

Study information

• Verified date: March 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Xiao Xiao, MD
• Phone: 021-68383104
• Email: xiaoxiao[@]renji.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival	Time to the first occurrence of liver transplant or death from any cause	From baseline to 60 months after baseline
Secondary	Liver-related death	Time to the first occurrence of liver transplant or death from liver-related cause	From baseline to 60 months after baseline
Secondary	Biochemical response	Proportion of patients who achieve complete biochemical response (normalisation of serum transaminases and immunoglobulin G below the ULN)	From baseline to 60 months after baseline
Secondary	Remission	Proportion of patients who achieve remission (hepatitis activity index<4/18)	From baseline to 60 months after baseline
Secondary	Complications	Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma	From baseline to 60 months after baseline