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NCT Number: NCT07378202

Machine Learning for Prediction of Therapy Response in Autoimmune Hepatitis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Digestive System Diseases Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Else Kroener Fresenius Center for Digital Health, Technical University Dresden, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Autoimmune hepatitis
  • Consent to provide data to the specific registry
  • available follow-up data at least within the first 12 months

Exclusion criteria

  • variant syndromes
  • extrahepatic autoimmune disease
  • immunosuppressive treatment at diagnosis

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Number of patients experiencing liver-related death or liver transplantation

    Time frame: From enrolment until the end of the study

  2. Number of patients with decompensation of liver disease

    Time frame: From enrolment until the end of the study

    Decompensation meaning a composite of new/worsening ascites, infection requiring hospitalization, acute-on-chronic liver failure, variceal bleeding, hepatic encephalopathy.

  3. Number of patients with complete biochemical response through study completion

    Time frame: through study completion, an expected average of 1 year

    Complete biochemical response is defined by normal AST, normal ALT and normal IgG

  4. Number of patients with histological remission of AIH through study completion

    Time frame: through study completion, an expected average of 1 year

    Histological remission is defined as modified hepatitis activity index below 4.

  5. Number of patients that develop cirrhosis through study completion

    Time frame: through study completion, an expected average of 1 year

    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.

  6. Number of patients with intolerance to primary treatment necessitating regimen change

    Time frame: 12 months

    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.

  7. Number of patients with non-response to primary treatment necessitating treatment change

    Time frame: 12 months

    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.

  8. 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

    Non-response is defined as persistently elevated aminotransferases and/or immunoglobulin G.

  9. Number of patients with normalization of aminotransferase levels in the blood irrespective of Immunoglobulin G levels

    Time frame: 6 months

    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.

  10. Number of patients with normalization of aminotransferase levels irrespective of Immunoglobulin G levels

    Time frame: 12 months

    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.

  11. Number of patients with steroid-free complete biochemical response

    Time frame: 6 months

    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).

  12. Number of patients with steroid-free complete biochemical response

    Time frame: 12 months

    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).

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Technische Universität Dresden

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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