Autoimmune HepatitisCAMERANCT05785793
Autoimmune Hepatitis Cohort in China
An observational study of Autoimmune Hepatitis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Autoimmune Hepatitis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2028
- How long will I take part?
- 5 Years
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients diagnosed as AIH in medical centers and outpatient clinics.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200001
Xiao Xiao, 021-68383104, xiaoxiao@renji.com
About this study
Official title: Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China
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.
Read the detailed description
Autoimmune hepatitis (AIH) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. Although relatively rare, the prevalence of AIH in China has been increasing in recent years, highlighting its significance as a public health issue. However, due to the wide variability in the clinical presentation and outcomes of AIH, diagnosing and managing the disease can be challenging. Moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of AIH in China is still limited.
To address this gap in knowledge, the investigators are conducting the Chinese AIH Cohort study, which collects data from approximately 20 sites across China on treatment progress and success in clinical routine. The study aims to evaluate the effectiveness and safety/tolerability of different AIH treatment options, including standard therapy, and second and third-line treatment options. The investigators also record the long-term prognosis of patients with AIH, tracking whether they achieve remission, require liver transplantation, or experience mortality. Risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of AIH in this population.
- Conditions
- Autoimmune Hepatitis
- Medical subject headings
- Hepatitis, Autoimmune
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival
Time to the first occurrence of liver transplant or death from any cause
Measured: From baseline to 60 months after baseline
Secondary outcomes (4)
Liver-related death
Time to the first occurrence of liver transplant or death from liver-related cause
Measured: From baseline to 60 months after baseline
Biochemical response
Proportion of patients who achieve complete biochemical response (normalisation of serum transaminases and immunoglobulin G below the ULN)
Measured: From baseline to 60 months after baseline
Remission
Proportion of patients who achieve remission (hepatitis activity index<4/18)
Measured: From baseline to 60 months after baseline
Complications
Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma
Measured: From baseline to 60 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (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.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maxiong, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiong Ma, MD,PHD, Study chair, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785793
- Sponsor's protocol ID
- AIH-CH
- Acronym
- CAMERA
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China
- ClinicalTrials.gov ID
- NCT05785793
- Acronym / sponsor ID
- CAMERA / AIH-CH
- Conditions
- Autoimmune Hepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 27 Mar 2023 (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 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.
Detailed description
Autoimmune hepatitis (AIH) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. Although relatively rare, the prevalence of AIH in China has been increasing in recent years, highlighting its significance as a public health issue. However, due to the wide variability in the clinical presentation and outcomes of AIH, diagnosing and managing the disease can be challenging. Moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of AIH in China is still limited.
To address this gap in knowledge, the investigators are conducting the Chinese AIH Cohort study, which collects data from approximately 20 sites across China on treatment progress and success in clinical routine. The study aims to evaluate the effectiveness and safety/tolerability of different AIH treatment options, including standard therapy, and second and third-line treatment options. The investigators also record the long-term prognosis of patients with AIH, tracking whether they achieve remission, require liver transplantation, or experience mortality. Risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of AIH in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients diagnosed as AIH in medical centers and outpatient clinics.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
Transplant free survival
Time frame: From baseline to 60 months after baseline
Time to the first occurrence of liver transplant or death from any cause
4 secondary outcomes
Liver-related death
Time frame: From baseline to 60 months after baseline
Biochemical response
Time frame: From baseline to 60 months after baseline
Remission
Time frame: From baseline to 60 months after baseline
Complications
Time frame: From baseline to 60 months after baseline
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 28 Mar 2023.
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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.
Xiong Ma, MD,PHD study chair
Renji Hospital, School of Medicine, Shanghai Jiao Tong 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 Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Mar 2023. 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 Xiao Xiao, MD (021-68383104, xiaoxiao@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival (time frame: From baseline to 60 months after baseline). 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 28 Mar 2023.