Acute Alcoholic HepatitisDIONYSOSNCT07262515
Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP
An observational study of Acute Alcoholic Hepatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Alcoholic Hepatitis
- How many people
- 1,400 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2024to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients younger than 18 years at diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Necker Hospital
Paris, 75015
Vincent MALLET, MD, PhD, vincent.mallet@aphp.fr
Camille Luya-Guedj, MSc, camille.luya-guedj@aphp.fr
About this study
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.
Read the detailed description
Acute alcoholic hepatitis (AAH) is characterized by acute liver inflammation caused by prolonged excessive alcohol intake. It is associated with jaundice, liver failure, and in severe cases, multi-organ failure and death. Current prognostic scores rely primarily on serum biomarkers of liver function but fail to account for systemic complications or histological features.
This retrospective, multicenter observational study conducted at AP-HP hospitals will analyze a large cohort of patients diagnosed with AAH since 2017. Data extracted from the AP-HP Clinical Data Warehouse (EDS) will include demographics, comorbidities, biological markers (liver and renal function tests, coagulation parameters, lactate), histological findings (necrosis, fibrosis, neutrophil infiltration, bilirubinostasis), microbiology results, prescribed medications, and outcomes such as infections, need for liver transplantation, and mortality.
The primary outcome is overall survival after diagnosis. Secondary outcomes include the impact of intermediate factors such as bacterial or fungal infections, alcohol withdrawal, organ failure, and transplantation on prognosis. Statistical analyses will combine classical survival models (Cox regression, Accelerated Failure Time models) and modern machine learning approaches (random forest, gradient boosting).
The goal is to develop integrative prognostic models that provide a more accurate and personalized assessment of prognosis in AAH, ultimately guiding clinical decision-making and improving patient management.
- Conditions
- Acute Alcoholic Hepatitis
- Keywords
- Acute Alcoholic Hepatitis, Machine Learning, Accelerated failure time, RWE epidemiology, Prognosis prediction
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From diagnosis up to 7 years after
Secondary outcomes (4)
Incidence of bacterial or fungal infections after diagnosis
Evaluate the impact of bacterial or fungal infections occurring after diagnosis of acute alcoholic hepatitis on the risk of death
Measured: Within 7 years after diagnosis
Requirement for liver transplantation
Evaluate the influence of the need for liver transplantation after diagnosis of acute alcoholic hepatitis on the risk of death
Measured: Within 7 years after diagnosis
Organ failure occurrence
Evaluate the impact of organ failure following a diagnosis of acute alcoholic hepatitis on the risk of death
Measured: within 7 years after diagnosis
Impact of alcohol withdrawal on prognosis
Measured: within 7 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start19 Jul 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Vincent MALLET, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262515
- Sponsor's protocol ID
- DAT23012
- Acronym
- DIONYSOS
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Epidemiology of Prognosis in Patients With Acute Alcoholic Hepatitis at AP-HP
- ClinicalTrials.gov ID
- NCT07262515
- Acronym / sponsor ID
- DIONYSOS / DAT23012
- Conditions
- Acute Alcoholic Hepatitis
- Keywords
- Acute Alcoholic Hepatitis, Machine Learning, Accelerated failure time, RWE epidemiology, Prognosis prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin, Ministry of Health, France
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Dec 2025 (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.
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.
Detailed description
Acute alcoholic hepatitis (AAH) is characterized by acute liver inflammation caused by prolonged excessive alcohol intake. It is associated with jaundice, liver failure, and in severe cases, multi-organ failure and death. Current prognostic scores rely primarily on serum biomarkers of liver function but fail to account for systemic complications or histological features.
This retrospective, multicenter observational study conducted at AP-HP hospitals will analyze a large cohort of patients diagnosed with AAH since 2017. Data extracted from the AP-HP Clinical Data Warehouse (EDS) will include demographics, comorbidities, biological markers (liver and renal function tests, coagulation parameters, lactate), histological findings (necrosis, fibrosis, neutrophil infiltration, bilirubinostasis), microbiology results, prescribed medications, and outcomes such as infections, need for liver transplantation, and mortality.
The primary outcome is overall survival after diagnosis. Secondary outcomes include the impact of intermediate factors such as bacterial or fungal infections, alcohol withdrawal, organ failure, and transplantation on prognosis. Statistical analyses will combine classical survival models (Cox regression, Accelerated Failure Time models) and modern machine learning approaches (random forest, gradient boosting).
The goal is to develop integrative prognostic models that provide a more accurate and personalized assessment of prognosis in AAH, ultimately guiding clinical decision-making and improving patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients younger than 18 years 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
Overall survival after diagnosis of acute alcoholic hepatitis
Time frame: From diagnosis up to 7 years after
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.
4 secondary outcomes
Incidence of bacterial or fungal infections after diagnosis
Time frame: Within 7 years after diagnosis
Requirement for liver transplantation
Time frame: Within 7 years after diagnosis
Organ failure occurrence
Time frame: within 7 years after diagnosis
Impact of alcohol withdrawal on prognosis
Time frame: within 7 years after diagnosis
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 3 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Vincent MALLET principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Alcoholic Hepatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Vincent MALLET, MD, PhD (01584142453 ext. +33, vincent.mallet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival after diagnosis of acute alcoholic hepatitis (time frame: From diagnosis up to 7 years after). 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 3 Dec 2025.