Machine Learning for Prediction of Therapy Response in Autoimmune Hepatitis

NCT07378202 · tracked via the Priya Life Science Germany tracker

Sponsor

Hannover Medical School

Phase

Observational

Started

2026-01-05

Last updated

2026-01-30

Condition(s) studied

Autoimmune Hepatitis

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of patients with complete biochemical response at 6 months after diagnosis — 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 — 12 months
Complete biochemical response is defined as normal aspartate amino transferase (AST), alanine aminotransferase (ALT) and immunoglobulin G (IgG).

Trial sites (2)

Facility	City	Region	Status
Else Kroener Fresenius Center for Digital Health, Technical University Dresden	Dresden	Germany
Hannover Medical School	Hanover	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07378202 on ClinicalTrials.gov ↗ ← All trials in Germany