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Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis (PRO-SURFASA)

Primary Purpose

Liver Failure, Acute, Hepatitis, Autoimmune, Organ Dysfunction Scores

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Corticosteroid therapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Failure, Acute focused on measuring Acute Severe AutoImmune Hepatitis (ASAIH), Decisional score, Prognostic score

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Acute autoimmune hepatitis defined by IAIHG score as "definite" or "probable" with a score ≥ 6.
  • International Normalized Ratio (INR) ≥ 1.5
  • Informed, written consent
  • Patient having the rights to French social insurance

Exclusion Criteria:

  • 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
  • Pregnant or lactating woman
  • Curator or guardianship or patient placed under judicial protection
  • Participation in other interventional research during the study

Sites / Locations

  • CHU Angers, Service Hepato-gastro-enterologie
  • CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs
  • APHP, Hopital Jean Verdier, Service Hepatologie
  • CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie
  • CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition
  • CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie
  • CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive
  • CHU Grenoble Alpes Hopital Nord, Service Hepato-gastro-enterologie
  • CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition
  • CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition
  • CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie
  • CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie
  • Hopital Saint Joseph, Service Hepato-gastro-enterologie
  • CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie
  • CHU Nice, Hopital de l'Archet 2, Service Hepatologie
  • CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie
  • AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie
  • APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie
  • AP-HP, Hopital Cochin Service Hepatologie
  • CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie
  • CHU La Miletrie, Service Hepato-gastro-enterologie
  • CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive
  • CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie
  • CHU Rouen, Service d'hepatogastro-enterologie
  • CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie
  • CHU Toulouse, Hopital Rangueil, Service Hepatologie
  • AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Corticosteroid therapy

Patient without corticosteroid therapy

Arm Description

Prednisone or Prednisolone or Methylprednisolone : Patient with ASAIH will be treated in oral or intravenous (IV) with high doses ( ≥ 1mg/kg/day) of corticosteroids (Prednisone or Prednisolone or Methylprednisolone) until relapse (confirmed by blood tests and clinical status) requiring an emergency Liver Transplantation (LT) or death.

Patient not treated will undergo to emergency Liver Transplantation (LT) or death.

Outcomes

Primary Outcome Measures

Prospectively validate the previously elaborated SURFASA-score, evaluating its ability to predict non-response outcome to corticosteroid therapy in a new population of patients with acute severe autoimmune hepatitis.
Patient response within 90 days to corticosteroid therapy defined as: responders (alive without LT) or non-responders (dead or transplanted) within 90 days since corticosteroid therapy introduction.

Secondary Outcome Measures

The association between infection occurrence and death during hospitalization
Documented infections during hospitalization
the management of infected ASAIH patients in usual practice
Antibiotic therapy : doses
The risk factors for early AIH flair after corticosteroid therapy response.
The frequency of AIH flair
The risk factors for AIH recurrence after liver transplantation
AIH recurrence
The evolution of patients after LT
Retransplantation, alive, death
The evolution of patients not treated with corticosteroids but meeting the inclusion and non-inclusion criteria
Retransplantation, alive, death
The prognostic factors for survival in patients treated with corticosteroids who underwent or not LT
quality of the graft, immunosuppression, rejection episode,
The association of histological features (liver biopsy) with response to corticosteroids and survival at 90 days since admission
Presence of centrilobular necrosis and inflammatory infiltration

Full Information

First Posted
June 7, 2022
Last Updated
October 2, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05473403
Brief Title
Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis
Acronym
PRO-SURFASA
Official Title
Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
All the interventions (blood samples, imagery examinations, visits, liver biopsy, corticosteroid therapy, liver transplantation) will be performed following the standard of care for ASAIH. The investigators of the participating centers will not change their standard management for the study protocol. The management will follow the recommendation of EASL CPGs. The prognostic score will allow to distinguish between patient's responders and non-responders to corticosteroid therapy in ASAIH. This knowledge will avoid the prolonged duration of the corticosteroid therapy in patients for whom this therapy is futile or harmful and rapidly select the patients for LT. Of course considering that the created score is decisional whether a patient is a candidate for LT, a prospective validation is mandatory to use it as a clinical tool for the day-to-day practice. This is the first prospective study on ASAIH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Acute, Hepatitis, Autoimmune, Organ Dysfunction Scores, Risk Factors
Keywords
Acute Severe AutoImmune Hepatitis (ASAIH), Decisional score, Prognostic score

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, prognostic, non-randomized, comparative, longitudinal, prospective, external validation cohort, which aims to evaluate a decisional score previously developed in a retrospective cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid therapy
Arm Type
Experimental
Arm Description
Prednisone or Prednisolone or Methylprednisolone : Patient with ASAIH will be treated in oral or intravenous (IV) with high doses ( ≥ 1mg/kg/day) of corticosteroids (Prednisone or Prednisolone or Methylprednisolone) until relapse (confirmed by blood tests and clinical status) requiring an emergency Liver Transplantation (LT) or death.
Arm Title
Patient without corticosteroid therapy
Arm Type
No Intervention
Arm Description
Patient not treated will undergo to emergency Liver Transplantation (LT) or death.
Intervention Type
Other
Intervention Name(s)
Corticosteroid therapy
Intervention Description
Administration of high doses of corticosteroids as early as possible. Patient non-responder to treatment should lead to listing for emergency liver transplantation (LT).
Primary Outcome Measure Information:
Title
Prospectively validate the previously elaborated SURFASA-score, evaluating its ability to predict non-response outcome to corticosteroid therapy in a new population of patients with acute severe autoimmune hepatitis.
Description
Patient response within 90 days to corticosteroid therapy defined as: responders (alive without LT) or non-responders (dead or transplanted) within 90 days since corticosteroid therapy introduction.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
The association between infection occurrence and death during hospitalization
Description
Documented infections during hospitalization
Time Frame
participation period (treatment+follow-up): 15 months
Title
the management of infected ASAIH patients in usual practice
Description
Antibiotic therapy : doses
Time Frame
participation period (treatment+follow-up): 15 months
Title
The risk factors for early AIH flair after corticosteroid therapy response.
Description
The frequency of AIH flair
Time Frame
D90
Title
The risk factors for AIH recurrence after liver transplantation
Description
AIH recurrence
Time Frame
participation period (treatment+follow-up): 15 months
Title
The evolution of patients after LT
Description
Retransplantation, alive, death
Time Frame
participation period (treatment+follow-up): 15 months
Title
The evolution of patients not treated with corticosteroids but meeting the inclusion and non-inclusion criteria
Description
Retransplantation, alive, death
Time Frame
participation period (treatment+follow-up): 15 months
Title
The prognostic factors for survival in patients treated with corticosteroids who underwent or not LT
Description
quality of the graft, immunosuppression, rejection episode,
Time Frame
participation period (treatment+follow-up): 15 months
Title
The association of histological features (liver biopsy) with response to corticosteroids and survival at 90 days since admission
Description
Presence of centrilobular necrosis and inflammatory infiltration
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Acute autoimmune hepatitis defined by IAIHG score as "definite" or "probable" with a score ≥ 6. International Normalized Ratio (INR) ≥ 1.5 Informed, written consent Patient having the rights to French social insurance Exclusion Criteria: 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 Pregnant or lactating woman Curator or guardianship or patient placed under judicial protection Participation in other interventional research during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleonora DE MARTIN, MD, PhD
Phone
33 (0)1.45.59.64.33
Email
eleonora.demartin@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Charles DUCLOS-VALLEE, MD, PhD
Phone
33 (0)1.45.59.64.28
Email
jean-charles.duclos-vallee@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleonora DE MARTIN, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers, Service Hepato-gastro-enterologie
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome BOURSIER, MD
Phone
33 (0)2.41.35.34.08
Email
JeBoursier@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Jerome BOURSIER, MD
Facility Name
CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent DI MARTINO, MD
Email
Vdimartino@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Vincent DI MARTINO, MD
Facility Name
APHP, Hopital Jean Verdier, Service Hepatologie
City
Bondy
ZIP/Postal Code
93140
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie GANNE, MD
Phone
33 (0)1.48.02.66.66
Email
nathalie.ganne@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nathalie GANNE, MD
Facility Name
CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noemi REBOUX, MD
Email
noemi.reboux@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Noemi REBOUX, MD
Facility Name
CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle OLLIVIER-HOURMAND, MD
Phone
33 (0)2.31.06.45.44
Email
ollivierhourmand-i@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Isabelle OLLIVIER-HOURMAND, MD
Facility Name
CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene BARRAUD, MD
Phone
33 (0)2.47.47.59.16
Email
h.barraud@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Helene BARRAUD, MD
Facility Name
CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne MINELLO, MD
Phone
33 (0)3.80.29.37.50
Email
anne.minello@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Anne MINELLO, MD
Facility Name
CHU Grenoble Alpes Hopital Nord, Service Hepato-gastro-enterologie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes BONADONA, MD
Phone
33 (0)4.76.76.62.57
Email
ABonadona@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Agnes BONADONA, MD
Facility Name
CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre LOUVET, MD
Email
alexandre.louvet@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Alexandre LOUVET, MD
Facility Name
CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryline DEBETTE-GRATIEN, MD
Phone
33 (0)5.55.05.66.21
Email
marilyne.gratien@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Maryline DEBETTE-GRATIEN, MD
Facility Name
CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome DUMORTIER, MD
Phone
33 (0)4.72.11.01.09
Email
jerome.dumortier@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jerome DUMORTIER, MD
Facility Name
CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Maria ANTONINI-MICHELLE, MD
Email
teresa.antonini@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Teresa Maria ANTONINI-MICHELLE, MD
Facility Name
Hopital Saint Joseph, Service Hepato-gastro-enterologie
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BOURLIERE, MD
Phone
33 (0)4 91 80 70 61
Email
mbourliere@hopital-saint-joseph.fr
First Name & Middle Initial & Last Name & Degree
Marc BOURLIERE, MD
Facility Name
CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy MEUNIER, MD
Phone
33 (0)4.67.33.66.33
Email
lucy.meunier@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Lucy MEUNIER, MD
Facility Name
CHU Nice, Hopital de l'Archet 2, Service Hepatologie
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolphe ANTY, MD
Phone
33 (0)4.92.03.63.85
Email
anty.r@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Rodolphe ANTY, MD
Facility Name
CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie
City
Orléans
ZIP/Postal Code
45100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal POTIER, MD
Phone
33 (0)2.38.22.96.43
Email
pascal.potier@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Pascal POTIER, MD
Facility Name
AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier CHAZOULLIERES, MD
Phone
33 (0)1.49.28.29.23
Email
olivier.chazouilleres@aphp.fr
First Name & Middle Initial & Last Name & Degree
Olivier CHAZOULLIERES, MD
Facility Name
APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marika RUDLER, MD
Phone
33 (0)1.42.17.56.91
Email
Marika.rudler@aphp.fr
First Name & Middle Initial & Last Name & Degree
Marika RUDLER, MD
Facility Name
AP-HP, Hopital Cochin Service Hepatologie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene FONTAINE, MD
Email
helene.fontaine@aphp.fr
First Name & Middle Initial & Last Name & Degree
Helene FONTAINE, MD
Facility Name
CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor DE LEDINGHEN, MD
Phone
33 (0)5.57.65.64.39
Email
victor.deledinghen@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Victor DE LEDINGHEN, MD
Facility Name
CHU La Miletrie, Service Hepato-gastro-enterologie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine SILVAIN, MD
Phone
33 (0)5.49.44.44.38
Email
c.silvain@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Christine SILVAIN, MD
Facility Name
CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra HEURGUE-BERLOT, MD
Phone
33 (0)3.26.78.78.78
Email
aheurgue@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Alexandra HEURGUE-BERLOT, MD
Facility Name
CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline HOUSSEL-DEBRY, MD
Phone
33 (0).99.28.42.98
Email
pauline.houssel-debry@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Pauline HOUSSEL-DEBRY, MD
Facility Name
CHU Rouen, Service d'hepatogastro-enterologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odile GORIA, MD
Email
Odile.Goria@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Odile GORIA, MD
Facility Name
CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille BESCH, MD
Phone
33 (0)3.88.12.74.48
Email
camille.besch@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Camille BESCH, MD
Facility Name
CHU Toulouse, Hopital Rangueil, Service Hepatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, MD
Phone
33 (0)5.61.77.25.27
Email
bureau.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, MD
Facility Name
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleonora DE MARTIN, MD, PhD
Phone
33 (0)1.45.59.64.33
Email
eleonora.demartin@aphp.fr
First Name & Middle Initial & Last Name & Degree
Eleonora DE MARTIN, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis

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