Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200001, China
Location status: Recruiting
NCT Number: NCT05785793
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.
Interested in participating?
Request Info14 year and older
All sexes
Observational
Shanghai, Shanghai Municipality, 200001, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From baseline to 60 months after baseline
Time to the first occurrence of liver transplant or death from any cause
Time frame: From baseline to 60 months after baseline
Time to the first occurrence of liver transplant or death from liver-related cause
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)
Time frame: From baseline to 60 months after baseline
Proportion of patients who achieve remission (hepatitis activity index<4/18)
Time frame: From baseline to 60 months after baseline
Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma
Contact information is provided by the study sponsor or research team.
Shanghai Jiao Tong University School of Medicine
Other
Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China
Acronym: CAMERA
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.
Published trials that share one or more normalized conditions with this study.
NCT05810480
Autoimmune Diseases, Autoimmune Hepatitis
Aachen, Germany
View Trial DetailsNCT07118657
Autoimmune Diseases, Autoimmune Hepatitis
New Delhi, National Capital Territory of Delhi, India
View Trial DetailsNCT06250309
Autoimmune Diseases, Autoimmune Hepatitis
Indianapolis, Indiana, United States
View Trial DetailsNCT06381453
Autoimmune Diseases, Autoimmune Hepatitis
Calgary, Alberta, Canada
View Trial Details