Machine Learning for Prediction of Therapy Response in Autoimmune Hepatitis

NCT07378202 | Active Not Recruiting

• 1 other identifier: AIH_ML_v1
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  12 months

Secondary Outcomes (12)

• Number of patients experiencing liver-related death or liver transplantation

  From enrolment until the end of the study

• Number of patients with decompensation of liver disease

  From enrolment until the end of the study

• Number of patients with complete biochemical response through study completion

  through study completion, an expected average of 1 year

• Number of patients with histological remission of AIH through study completion

  through study completion, an expected average of 1 year

• Number of patients that develop cirrhosis through study completion

  through study completion, an expected average of 1 year

Study Arms (5)

R-LIVER Registry

AIH registry from Edmonton, Canada

CANAL Registry

IAIHG Registry

ColHAI Registry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 ).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hannover Medical School: lead
• Technische Universität Dresden: collaborator

Study Sites (2)

Else Kroener Fresenius Center for Digital Health, Technical University Dresden

Dresden, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

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

Study Officials

• Bastian Engel, MD

  Hannover Medical School, Hannover, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist, Clinician Scientist, Principal Investigator

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 30, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)