A Study on Factors of Biochemical Response in Autoimmune Hepatitis
NCT ID: NCT06356506
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
630 participants
OBSERVATIONAL
2024-05-01
2034-05-01
Brief Summary
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Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Modeling group
The data of modeling group is used to construct a predictive model of AIH end-point events.
No interventions assigned to this group
Validation group
Validation group is used to validate the predictive model externally.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. AIH simplified score ≥6 and/or AIH revised score ≥10;
3. Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
4. Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
5. Agree to participate in this study and sign the informed consent form.
Exclusion Criteria
2. concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
3. bone marrow or liver transplantation;
4. incomplete baseline medical history and laboratory examination results;
5. for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
6. Pregnancy or lactation;
7. patients with contraindications to glucocorticoid/immunosuppressive therapy;
8. complicated with other malignant tumors;
9. complicated with mental disorders.
18 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Zhao Xinyan
Director, Principal Investigator, Clinical Professor
Principal Investigators
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Xinyan Zhao
Role: STUDY_CHAIR
Beijing Friendship Hospital
Zhengsheng Zou
Role: STUDY_CHAIR
Beijing 302 Hospital
Yu Chen
Role: PRINCIPAL_INVESTIGATOR
Beijing You 'an Hospital, Capital Medical University
Jia Li
Role: PRINCIPAL_INVESTIGATOR
Tianjin Second People's Hospital
Jingshou Chen
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Xiamen University
Liang Wang
Role: PRINCIPAL_INVESTIGATOR
Lanzhou University Second Hospital
Huahua Wang
Role: PRINCIPAL_INVESTIGATOR
Jiaozuo People's Hospital
Xiaoli Hu
Role: PRINCIPAL_INVESTIGATOR
Heilongjiang Provincinal Hospital
Pingying Li
Role: PRINCIPAL_INVESTIGATOR
Qinghai People's Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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2022-P2-338-01
Identifier Type: -
Identifier Source: org_study_id
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