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Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-06-01
Completion Date
2028-06-30
Last Updated
2024-03-13
Healthy Volunteers
No
Interventions
Corticosteroid therapy
Administration of high doses of corticosteroids as early as possible. Patient non-responder to treatment should lead to listing for emergency liver transplantation (LT).
Locations (26)
CHU Angers, Service Hepato-gastro-enterologie
Angers, France
CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs
Besançon, France
APHP, Hopital Avicenne, Service Hepatologie et Oncologie Hépatique
Bobigny, France
CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie
Brest, France
CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition
Caen, France
CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie
Chambray-lès-Tours, France
CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive
Dijon, France
CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition
Lille, France
CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition
Limoges, France
CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie
Lyon, France
CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie
Lyon, France
Hopital Saint Joseph, Service Hepato-gastro-enterologie
Marseille, France
CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie
Montpellier, France
CHU Nice, Hopital de l'Archet 2, Service Hepatologie
Nice, France
CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie
Orléans, France
AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie
Paris, France
APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie
Paris, France
AP-HP, Hopital Cochin Service Hepatologie
Paris, France
CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie
Pessac, France
CHU La Miletrie, Service Hepato-gastro-enterologie
Poitiers, France
CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive
Reims, France
CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie
Rennes, France
CHU Rouen, Service d'hepatogastro-enterologie
Rouen, France
CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie
Strasbourg, France
CHU Toulouse, Hopital Rangueil, Service Hepatologie
Toulouse, France
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, France