Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP

NCT07262515 | Recruiting

• 1 other identifier: DAT23012
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Acute alcoholic hepatitis (AAH) is a severe liver disease that often occurs in individuals with prolonged excessive alcohol consumption. Patients face a high risk of liver failure, complications, and death, despite available treatments. Current prognostic scores based on blood tests provide limited accuracy and do not capture the full complexity of the disease. The purpose of this study is to improve the prediction of patient outcomes after a diagnosis of acute alcoholic hepatitis. By integrating clinical, biological, and histological information collected from the AP-HP data warehouse, the investigators aim to identify more reliable prognostic markers. This could help physicians better tailor treatments and improve survival of patients affected by this condition.

Conditions

Acute Alcoholic Hepatitis

Keywords

Acute Alcoholic Hepatitis; Machine Learning; Accelerated failure time; RWE epidemiology; Prognosis prediction

Outcome Measures

Primary Outcomes (1)

• Overall survival after diagnosis of acute alcoholic hepatitis

  Overall survival will be assessed using mortality data recorded in the AP-HP Clinical Data Warehouse. The objective is to evaluate prognosis and identify risk factors associated with death after a diagnosis of acute alcoholic hepatitis, by integrating clinical, biological, and histological information. Survival will be analysed at multiple time points, including 1 month, 6 months, and 1 year after diagnosis.

  From diagnosis up to 7 years after

Secondary Outcomes (4)

• Incidence of bacterial or fungal infections after diagnosis

  Within 7 years after diagnosis

• Requirement for liver transplantation

  Within 7 years after diagnosis

• Organ failure occurrence

  within 7 years after diagnosis

• Impact of alcohol withdrawal on prognosis

  within 7 years after diagnosis

Study Arms (1)

Patients with acute alcoholic hepatitis

All adult patients diagnosed with acute alcoholic hepatitis at AP-HP hospitals, identified using ICD-10 codes (K701), pathology reports, and clinical data.

Eligibility Criteria

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

Study Population

Patients diagnosed with acute alcoholic hepatitis across all AP-HP hospitals. Data will be collected retrospectively from the AP-HP Clinical Data Warehouse (EDS).

You may qualify if:

• Adult patients (≥18 years)
• Diagnosis of acute alcoholic hepatitis (ICD10 K701 or occurrence of the terms "HAA" (French translation of "AAH" or "hépatite alcoolique aiguë" (French translation of "acute alcoholic hepatitis") in a pathology report, followed by manual verification

You may not qualify if:

• \- Patients younger than 18 years at diagnosis

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator
• Ministry of Health, France: collaborator

Study Sites (1)

Necker Hospital

Paris, 75015, France

RECRUITING

Study Officials

• Vincent MALLET

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent MALLET, MD, PhD

CONTACT

01584142453; vincent.mallet@aphp.fr

Camille Luya-Guedj, MSc

CONTACT

0144494327; camille.luya-guedj@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: July 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)