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A real-world study focusing on liver immunity on patients with autoimmune hepatitis

A real-world study focusing on liver immunity on patients with autoimmune hepatitis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074836
Enrollment
Unknown
Registered
2023-08-17
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune hepatitis

Interventions

Simple symptomatic support treatment group:N/A
Immunosuppressive therapy group:N/A

Sponsors

the frist affiliated hospital of wenzhou medical university,wenzhou, china
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) 18-70 years old (including 18-70 years old); (2) elevated levels of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST); (3) one or more high titers of autoantibodies in serum; (4) IgG and / or ?-globulin elevated (5) liver histological examination showed moderate and severe interface hepatitis, lymphatic-plasma cell infiltration in and around the portal area, moderate inflammation in lobules or other special types of AIH. (6) AIH simplified diagnostic integral system and comprehensive diagnostic integral system > 10 points. Those who meet any of the above 1 + items can join the group.

Exclusion criteria

Exclusion criteria: (1) patients with liver diseases such as viral hepatitis, metabolic fatty liver disease and Wilson disease; (2) pregnant and lactating women and patients preparing to give birth in the near future; (3) history of serious heart disease, including unstable or uncontrolled heart disease within 6 months; (4) history of mental illness; (5) uncontrolled epilepsy; (6) alcoholics or drug addicts who did not quit; (7) other conditions that the competent physician thought was not suitable to be included in the group.

Design outcomes

Secondary

MeasureTime frame
Liver function test;

Primary

MeasureTime frame
Degree of liver inflammation;Abdominal CT scan;Serum autoantibodies;BMI;Intestine microbiota;Transcription of liver cells;

Countries

china

Contacts

Public ContactLu, Mingqin

the frist affiliated hospital of wenzhou medical university

13506662567@163.com+86 135 0666 2567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026