Autoimmune Hepatitis Cohort in China
ConditionAutoimmune Hepatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The patients diagnosed as AIH in medical centers and outpatient clinics.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Transplant free survival
Time to the first occurrence of liver transplant or death from any cause
Time frame
From baseline to 60 months after baselineSecondary outcomes
1
Liver-related death
Time to the first occurrence of liver transplant or death from liver-related cause
Time frame
From baseline to 60 months after baseline2
Biochemical response
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 baseline3
Remission
Proportion of patients who achieve remission (hepatitis activity index\<4/18)
Time frame
From baseline to 60 months after baseline4
Complications
Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma
Time frame
From baseline to 60 months after baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov