| NCT ID | NCT05785793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Autoimmune Hepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-02-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Xiong Ma, MD,PHD
STUDY CHAIR
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Frequently Asked Questions
Who can join the NCT05785793 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Autoimmune Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05785793 currently recruiting?
Yes, NCT05785793 is actively recruiting participants. Contact the research team at xiaoxiao@renji.com for enrollment information.
Where is the NCT05785793 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05785793 clinical trial?
NCT05785793 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Xiong Ma, MD,PHD at Renji Hospital, School of Medicine, Shanghai Jiao Tong University.. The trial plans to enroll 1,000 participants.