Autoimmune HepatitisNCT06356506
A Study on Factors of Biochemical Response in Autoimmune Hepatitis
An observational study of Autoimmune Hepatitis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are: Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hepatitis
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 May 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AIH patients who fulfilled the inclusion and exclusion criteria were enrolled in this study.
Who may be able to join
- ≥18 years old at the time of onset;
- AIH simplified score ≥6 and/or AIH revised score ≥10;
- Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
- Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
- Agree to participate in this study and sign the informed consent form.
Who cannot join
- concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
- concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
- bone marrow or liver transplantation;
- incomplete baseline medical history and laboratory examination results;
- for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
- Pregnancy or lactation;
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- patients with contraindications to glucocorticoid/immunosuppressive therapy;
- complicated with other malignant tumors;
- complicated with mental disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
About this study
Official title: A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis
The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:
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.
Read the detailed description
This study aims to establish a high-quality, standardized prospective cohort of AIH with regular follow-up, clarify the clinical characteristics of AIH in China, construct a prognostic model, and explore new serum markers or AIH gene susceptibility, so as to provide key clinical evidence for the prevention and treatment of AIH in China.
- Conditions
- Autoimmune Hepatitis
- Keywords
- Autoimmune hepatitis, Biochemical response, Prognosis, Immunosuppressive therapy
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Modeling group | The data of modeling group is used to construct a predictive model of AIH end-point events. | |
| Validation group | Validation group is used to validate the predictive model externally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase (ALT) recovery
Normalization of ALT
Measured: From time of enrollment to the date of first ALT recovery, assessed up to 120 months
Aspartate transaminase (AST) recovery
Normalization of AST
Measured: From time of enrollment to the date of first AST recovery, assessed up to 120 months
Immunoglobulin G (IgG) recovery
Normalization of IgG
Measured: From time of enrollment to the date of first IgG recovery, assessed up to 120 months
Death
Patients die because of liver diseases
Measured: From time of enrollment to the date of death from liver disease, assessed up to 120 months
Liver transplantaiton
Patients have liver transplantation because of AIH
Measured: From time of enrollment to the date of liver transplantation, assessed up to 120 months
Progression to hepatocellular carcinoma (HCC)
Patients progress to hepatocellular carcinoma due to poor treatment response
Measured: From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2034 (estimated)
- Study completion1 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Xinyan, Beijing Friendship Hospital
- Investigators
- Xinyan Zhao, Study chair, Beijing Friendship HospitalZhengsheng Zou, Study chair, Beijing 302 HospitalYu Chen, Principal investigator, Beijing You 'an Hospital, Capital Medical UniversityJia Li, Principal investigator, Tianjin Second People's HospitalJingshou Chen, Principal investigator, The First Affiliated Hospital of Xiamen UniversityLiang Wang, Principal investigator, Lanzhou University Second HospitalHuahua Wang, Principal investigator, Jiaozuo People's HospitalXiaoli Hu, Principal investigator, Heilongjiang Provincinal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356506
- Sponsor's protocol ID
- 2022-P2-338-01
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT06356506
- Acronym / sponsor ID
- 2022-P2-338-01
- Conditions
- Autoimmune Hepatitis
- Keywords
- Autoimmune hepatitis, Biochemical response, Prognosis, Immunosuppressive therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2034 (estimated)
- Study completion
- 1 May 2034 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:
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.
Detailed description
This study aims to establish a high-quality, standardized prospective cohort of AIH with regular follow-up, clarify the clinical characteristics of AIH in China, construct a prognostic model, and explore new serum markers or AIH gene susceptibility, so as to provide key clinical evidence for the prevention and treatment of AIH in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling group | – | –The data of modeling group is used to construct a predictive model of AIH end-point events. |
| Validation group | – | –Validation group is used to validate the predictive model externally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AIH patients who fulfilled the inclusion and exclusion criteria were enrolled in this study.
Key inclusion criteria (5 listed)
- ≥18 years old at the time of onset;
- AIH simplified score ≥6 and/or AIH revised score ≥10;
- Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
- Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
- Agree to participate in this study and sign the informed consent form.
Key exclusion criteria (9 listed)
- concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
- concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
- bone marrow or liver transplantation;
- incomplete baseline medical history and laboratory examination results;
- for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alanine aminotransferase (ALT) recovery
Time frame: From time of enrollment to the date of first ALT recovery, assessed up to 120 months
Normalization of ALT
Aspartate transaminase (AST) recovery
Time frame: From time of enrollment to the date of first AST recovery, assessed up to 120 months
Normalization of AST
Immunoglobulin G (IgG) recovery
Time frame: From time of enrollment to the date of first IgG recovery, assessed up to 120 months
Normalization of IgG
Death
Time frame: From time of enrollment to the date of death from liver disease, assessed up to 120 months
Patients die because of liver diseases
Liver transplantaiton
Time frame: From time of enrollment to the date of liver transplantation, assessed up to 120 months
Patients have liver transplantation because of AIH
Progression to hepatocellular carcinoma (HCC)
Time frame: From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months
Patients progress to hepatocellular carcinoma due to poor treatment response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinyan Zhao study chair
Beijing Friendship Hospital
Zhengsheng Zou study chair
Beijing 302 Hospital
Yu Chen principal investigator
Beijing You 'an Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hepatitis, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Su (18810639513, suyu_7912@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine aminotransferase (ALT) recovery (time frame: From time of enrollment to the date of first ALT recovery, assessed up to 120 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.