Autoimmune Hepatitis Cohort in China

NCT05785793 | Recruiting

• 1 other identifier: AIH-CH
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (1)

• Transplant free survival

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

  From baseline to 60 months after baseline

Secondary Outcomes (4)

• Liver-related death

  From baseline to 60 months after baseline

• Biochemical response

  From baseline to 60 months after baseline

• Remission

  From baseline to 60 months after baseline

• Complications

  From baseline to 60 months after baseline

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients diagnosed as AIH in medical centers and outpatient clinics.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and liver biopsy specimens

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiong Ma, MD,PHD

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Xiao Xiao, MD

CONTACT

021-68383104; xiaoxiao@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology and Hepatology, Renji Hospital

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CN (1)