Informations générales (source: ClinicalTrials.gov)
Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2024
juin 2028
03 décembre 2025
Autoimmune hepatitis (AIH) is a chronic liver disease, which is characterized by the
increase of immunoglobulin G (IgG) level, the presence of auto-antibodies and a typical
histology, in the absence of other liver disease.
Due to the heterogeneity of AIH manifestations, different scoring systems have been
validated in order to make a reliable diagnosis. The two most recent scoring systems are:
the revised International Autoimmune Hepatitis Group (IAIHG) criteria and the IAIHG
simplified criteria. The second one is recommended by the European Association for the
Study of the Liver (EASL) clinical practice guidelines (CPGs).
The EASL clinical practice guidelines suggests that the treatment of ASAIH (Acute Severe
AIH) is high doses of corticosteroids (superior to 1mg/kg/day) as early as possible and a
lack of improvement within seven days should lead to listing for emergency liver
transplantation (LT). However, the "lack of improvement" is not objectively defined and
the grading of recommendation is III (Opinions of respected authorities).
The hypothesis of the study is that the previously developed decisional score on a
retrospective series will prospectively allow the differentiation between patients with
ASAIH (Acute Severe AIH) who respond to corticosteroid therapy and should be maintained
on treatment and patients who do not respond and should be rapidly evaluated for LT. The
score will be computed at day 3 since corticosteroid introduction.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:41:26 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Paul Brousse | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition - 59037 - Lille - France | Alexandre LOUVET, MD | Contact (sur clinicalTrials) | |||
| CHU Angers, Service Hepato-gastro-enterologie - 49933 - Angers - France | Adrien LANNES, MD | Contact (sur clinicalTrials) | |||
| CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie - 33604 - Pessac - France | Victor DE LEDINGHEN, MD | Contact (sur clinicalTrials) | |||
| CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie - 29609 - Brest - France | Noemi REBOUX, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition - 14033 - Caen - France | Isabelle OLLIVIER-HOURMAND, MD | Contact (sur clinicalTrials) | |||
| CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie - 35000 - Rennes - France | Pauline HOUSSEL-DEBRY, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive - 21079 - Dijon - France | Anne MINELLO, MD | Contact (sur clinicalTrials) | |||
| CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie - 69003 - Lyon - France | Jerome DUMORTIER, MD | Contact (sur clinicalTrials) | |||
| CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs - 25030 - Besançon - France | Vincent DI MARTINO, MD | Contact (sur clinicalTrials) | |||
| CHU La Miletrie, Service Hepato-gastro-enterologie - 86000 - Poitiers - France | Christine SILVAIN, MD | Contact (sur clinicalTrials) | |||
| CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition - 87042 - Limoges - France | Marilyne DEBETTE-GRATIEN, MD | Contact (sur clinicalTrials) | |||
| CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie - 69317 - Lyon - France | Teresa Maria ANTONINI-MICHELLE, MD | Contact (sur clinicalTrials) | |||
| CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie - 34295 - Montpellier - France | Lucy MEUNIER, MD | Contact (sur clinicalTrials) | |||
| CHU Nice, Hopital de l'Archet 2, Service Hepatologie - 06200 - Nice - France | Rodolphe ANTY, MD | Contact (sur clinicalTrials) | |||
| CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie - 45100 - Orléans - France | Pascal POTIER, MD | Contact (sur clinicalTrials) | |||
| CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive - 51092 - Reims - France | Alexandra HEURGUE-BERLOT, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen, Service d'hepatogastro-enterologie - 76031 - Rouen - France | Odile GORIA, MD | Contact (sur clinicalTrials) | |||
| CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie - 67200 - Strasbourg - France | Camille BESCH, MD | Contact (sur clinicalTrials) | |||
| CHU Toulouse, Hopital Rangueil, Service Hepatologie - 31059 - Toulouse - France | Christophe BUREAU, MD | Contact (sur clinicalTrials) | |||
| CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie - 37170 - Chambray-lès-Tours - France | Helene BARRAUD, MD | Contact (sur clinicalTrials) | |||
| Hopital Saint Joseph, Service Hepato-gastro-enterologie - 13285 - Marseille - France | Olivia PIETRI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years
- Strong clinical suspicion of severe acute autoimmune hepatitis defined by the
presence of increased IgG and/or autoantibodies and/or histology characteristic of
the disease in the absence of other causes of severe acute hepatitis.
- International Normalized Ratio (INR) ≥ 1.5
- Informed, written consent
- Patient having the rights to French social insurance
- Age ≥ 18 years
- Strong clinical suspicion of severe acute autoimmune hepatitis defined by the
presence of increased IgG and/or autoantibodies and/or histology characteristic of
the disease in the absence of other causes of severe acute hepatitis.
- International Normalized Ratio (INR) ≥ 1.5
- Informed, written consent
- Patient having the rights to French social insurance
- Previous medical history of chronic liver disease including autoimmune liver disease
(AIH, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC) ,
alcoholic hepatitis etc.)
- Other causes of acute severe hepatitis:
- Hepatitis A Virus (HAV) hepatitis, defined by HAV Immunoglobulin M (IgM)
antibodies
- Hepatitis B Virus (HBV) hepatitis, defined by HBs antigen and HBV IgM
antibodies
- Hepatitis E Virus (HEV) hepatitis, defined by HEV IgM antibodies or positive
HEV-RNA in immunosuppressed patients
- Drug induced hepatitis, histologically proved or induced by well-known
hepatotoxic substances
- Acute hypoxemic hepatitis, context of shock, hypoxemia or heat shock
- Budd-Chiari syndrome, diagnosed by imagery (Doppler ultrasound, CT scan)
- Acute hepatitis in the context of a HELLP (Hemolysis, Elevated Liver enzymes
and a Low Platelet count) syndrome or acute fatty liver of pregnancy
- Use of corticosteroids 1 month before inclusion
- Pregnant or lactating woman
- Curator or guardianship or patient placed under judicial protection
- Participation in other interventional research during the study