Autoimmune HepatitisNCT07378202
Machine Learning for Prediction of Therapy Response in Autoimmune Hepatitis
An observational study of Autoimmune Hepatitis, run by Hannover Medical School at 2 sites in Germany.
Trial summary
The 5th International Autoimmune Hepatitis Group (IAIHG) research workshop emphasized the integration of large clinical cohorts with artificial intelligence (AI) for enhanced prediction of therapy responses and outcomes in Autoimmune Hepatitis (AIH). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Hepatitis
- How many people
- 5,000 participants
- Where
- 2 sitesGermany
- Study dates
- 5 Jan 2026to Jan 2028
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This project utilizes already established registries of patients with autoimmune hepatitis (AIH) from the international autoimmune hepatitis group (IAIHG), the European Reference Network on Rare liver diseases (R-LIVER), the spanish network on autoimmune hepatitis (colHAI) and the canadian network on autoimmune hepatitis (CANAL). Initial reports on the patient populations within the respective registries were separately published (doi: 10.1111/liv.16035, doi: 10.1097/HEP.0000000000000589, 10.1016/j.jhep.2024.03.021, 10.1097/HEP.0000000000000018 ).
Who may be able to join
- Diagnosis of Autoimmune hepatitis
- Consent to provide data to the specific registry
- available follow-up data at least within the first 12 months
Who cannot join
- variant syndromes
- extrahepatic autoimmune disease
- immunosuppressive treatment at diagnosis
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Else Kroener Fresenius Center for Digital Health, Technical University Dresden
Dresden
Hannover Medical School
Hanover, 30625
About this study
The 5th International Autoimmune Hepatitis Group (IAIHG) research workshop emphasized the integration of large clinical cohorts with artificial intelligence (AI) for enhanced prediction of therapy responses and outcomes in Autoimmune Hepatitis (AIH). This project aims to develop and validate machine learning (ML) models using data from the R-Liver registry and other international cohorts. After rigorous preprocessing to ensure data uniformity and quality, the investigators will identify and characterize factors influencing therapy response. They will then implement ML models to predict complete biochemical response (CBR) at 6 and 12 months, using five-fold cross-validation, and validate these models in external cohorts from Spain, Canada, and the international AIH group, ensuring robustness and generalizability.
Finally, the investigators will prospectively validate the models in newly registered cases, assessing both short-term and long-term outcomes. This project seeks to advance personalized treatment strategies in AIH, facilitating timely adjustments in therapy and improving patient prognosis through AI-driven decision support. This projects' interdisciplinary team, with expertise in clinical AI and hepatology, is well-equipped to address these challenges and enhance the clinical management of AIH.
- Conditions
- Autoimmune Hepatitis
- Keywords
- machine learning, registry, therapeutic response
- 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 |
|---|---|---|
| R-LIVER Registry | Not described | |
| AIH registry from Edmonton, Canada | Not described | |
| CANAL Registry | Not described | |
| IAIHG Registry | Not described | |
| ColHAI Registry | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete biochemical response at 6 months after diagnosis
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).
Measured: 6 months
Number of patients with complete biochemical response at 12 months after diagnosis
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).
Measured: 12 months
Secondary outcomes (12)
Number of patients experiencing liver-related death or liver transplantation
Measured: From enrolment until the end of the study
Number of patients with decompensation of liver disease
Decompensation meaning a composite of new/worsening ascites, infection requiring hospitalization, acute-on-chronic liver failure, variceal bleeding, hepatic encephalopathy.
Measured: From enrolment until the end of the study
Number of patients with complete biochemical response through study completion
Complete biochemical response is defined by normal AST, normal ALT and normal IgG
Measured: through study completion, an expected average of 1 year
Number of patients with histological remission of AIH through study completion
Histological remission is defined as modified hepatitis activity index below 4.
Measured: through study completion, an expected average of 1 year
Number of patients that develop cirrhosis through study completion
Cirrhosis is defined by imaging findings indicative of cirrhosis, histological staging indicating fibrosis or liver stiffness measurement that is in line with a cirrhotic liver.
Measured: through study completion, an expected average of 1 year
Number of patients with intolerance to primary treatment necessitating regimen change
Intolerance to treatment is reported by respective patients and assessed by respective treating physicians. It is expected to be gastrointestinal side effects and hematological side effects (cytopenias) that may typically occur from treatment with azathioprine or mycophenolate mofetil which lead to change of treatment regimens in patients with autoimmune hepatitis.
Measured: 12 months
Number of patients with non-response to primary treatment necessitating treatment change
Non-Response ist defined as persistently elevated aspartate aminotransferase, alanine aminotransferase and/or immunoglobulin G. It is considered a reason to change the therapeutic regimen.
Measured: 12 months
Number of patients with third line treatment due to non-response to obtain biochemical response through study completion
Non-response is defined as persistently elevated aminotransferases and/or immunoglobulin G.
Measured: through study completion, an expected average of 1 year
Number of patients with normalization of aminotransferase levels in the blood irrespective of Immunoglobulin G levels
Aminotransferases are alanine aminotransferase and asparatate aminotransferase. These enzymes indicate liver injury and are considered response markers measured from blood in clinical routine to assess therapeutic response in autoimmune hepatitis.
Measured: 6 months
Number of patients with normalization of aminotransferase levels irrespective of Immunoglobulin G levels
Aminotransferases are alanine aminotransferase and asparatate aminotransferase. These enzymes indicate liver injury and are considered response markers measured from blood in clinical routine to assess therapeutic response in autoimmune hepatitis.
Measured: 12 months
Number of patients with steroid-free complete biochemical response
Complete biochemical response is defined by normal blood levels for aminotransferases and normal immunoglobulin G. This outcome measure assesses this parameter in relation to the fact if the patient needed corticosteroid-therapy to obtain this outcome or if the patient only needed other immunosuppressive drugs (e.g. azathioprine, mycophenolate mofetil).
Measured: 6 months
Number of patients with steroid-free complete biochemical response
Complete biochemical response is defined by normal blood levels for aminotransferases and normal immunoglobulin G. This outcome measure assesses this parameter in relation to the fact if the patient needed corticosteroid-therapy to obtain this outcome or if the patient only needed other immunosuppressive drugs (e.g. azathioprine, mycophenolate mofetil).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Jan 2026
- Primary completion5 Jan 2027 (estimated)
- Study completionJan 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
- Case only
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden
- Responsible party
- Principal investigator, Engel, Bastian Dr., Hannover Medical School
- Investigators
- Bastian Engel, MD, Principal investigator, Hannover Medical School, Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378202
- Sponsor's protocol ID
- AIH_ML_v1
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized IPD will be shared for the purpose of the study by the respective registries with the research team of this study. IPD request need to be directed directly to the respective officials of the different registries.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning for Prediction of Therapy Response in Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT07378202
- Acronym / sponsor ID
- AIH_ML_v1
- Conditions
- Autoimmune Hepatitis
- Keywords
- machine learning, registry, therapeutic response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Technische Universität Dresden
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Jan 2026 (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 5th International Autoimmune Hepatitis Group (IAIHG) research workshop emphasized the integration of large clinical cohorts with artificial intelligence (AI) for enhanced prediction of therapy responses and outcomes in Autoimmune Hepatitis (AIH). This project aims to develop and validate machine learning (ML) models using data from the R-Liver registry and other international cohorts. After rigorous preprocessing to ensure data uniformity and quality, the investigators will identify and characterize factors influencing therapy response. They will then implement ML models to predict complete biochemical response (CBR) at 6 and 12 months, using five-fold cross-validation, and validate these models in external cohorts from Spain, Canada, and the international AIH group, ensuring robustness and generalizability.
Finally, the investigators will prospectively validate the models in newly registered cases, assessing both short-term and long-term outcomes. This project seeks to advance personalized treatment strategies in AIH, facilitating timely adjustments in therapy and improving patient prognosis through AI-driven decision support. This projects' interdisciplinary team, with expertise in clinical AI and hepatology, is well-equipped to address these challenges and enhance the clinical management of AIH.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| R-LIVER Registry | – | – |
| AIH registry from Edmonton, Canada | – | – |
| CANAL Registry | – | – |
| IAIHG Registry | – | – |
| ColHAI Registry | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This project utilizes already established registries of patients with autoimmune hepatitis (AIH) from the international autoimmune hepatitis group (IAIHG), the European Reference Network on Rare liver diseases (R-LIVER), the spanish network on autoimmune hepatitis (colHAI) and the canadian network on autoimmune hepatitis (CANAL). Initial reports on the patient populations within the respective registries were separately published (doi: 10.1111/liv.16035, doi: 10.1097/HEP.0000000000000589, 10.1016/j.jhep.2024.03.021, 10.1097/HEP.0000000000000018 ).
Key inclusion criteria (3 listed)
- Diagnosis of Autoimmune hepatitis
- Consent to provide data to the specific registry
- available follow-up data at least within the first 12 months
Key exclusion criteria (3 listed)
- variant syndromes
- extrahepatic autoimmune disease
- immunosuppressive treatment at diagnosis
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
Number of patients with complete biochemical response at 6 months after diagnosis
Time frame: 6 months
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).
Number of patients with complete biochemical response at 12 months after diagnosis
Time frame: 12 months
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).
12 secondary outcomes
Number of patients experiencing liver-related death or liver transplantation
Time frame: From enrolment until the end of the study
Number of patients with decompensation of liver disease
Time frame: From enrolment until the end of the study
Number of patients with complete biochemical response through study completion
Time frame: through study completion, an expected average of 1 year
Number of patients with histological remission of AIH through study completion
Time frame: through study completion, an expected average of 1 year
Number of patients that develop cirrhosis through study completion
Time frame: through study completion, an expected average of 1 year
Number of patients with intolerance to primary treatment necessitating regimen change
Time frame: 12 months
Number of patients with non-response to primary treatment necessitating treatment change
Time frame: 12 months
Number of patients with third line treatment due to non-response to obtain biochemical response through study completion
Time frame: through study completion, an expected average of 1 year
Number of patients with normalization of aminotransferase levels in the blood irrespective of Immunoglobulin G levels
Time frame: 6 months
Number of patients with normalization of aminotransferase levels irrespective of Immunoglobulin G levels
Time frame: 12 months
Number of patients with steroid-free complete biochemical response
Time frame: 6 months
Number of patients with steroid-free complete biochemical response
Time frame: 12 months
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 30 Jan 2026.
- Individual participant dataSharing planned: No. Anonymized IPD will be shared for the purpose of the study by the respective registries with the research team of this study. IPD request need to be directed directly to the respective officials of the different registries.
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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. This study is not recruiting at the moment.
Bastian Engel, MD principal investigator
Hannover Medical School, Hannover, Germany
2 sites 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 Hannover Medical School at 2 sites in Germany.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complete biochemical response at 6 months after diagnosis (time frame: 6 months). The study lists 2 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 30 Jan 2026.