Liver Failure, AcutePRO-SURFASANCT05473403
Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis
A study testing Corticosteroid therapy in people with Liver Failure, Acute and Hepatitis, Autoimmune, run by Assistance Publique - Hôpitaux de Paris at 26 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Liver Failure, Acute, Hepatitis, Autoimmune, Organ Dysfunction Scores
- What is being tested?
- Corticosteroid therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 26 sitesFrance
- Study dates
- 1 Jun 2024to 30 Jun 2028
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
France26 sites
CHU Angers, Service Hepato-gastro-enterologie
Angers, 49933
Adrien LANNES, MD, 33 (0)2.41.35.31.42, adrien.lannes@chu-angers.fr
Adrien LANNES, MD
CHU Jean Minjoz Besançon, Service d'hepatologie et de soins intensifs digestifs
Besançon, 25030
Vincent DI MARTINO, MD, Vdimartino@chu-besancon.fr
Vincent DI MARTINO, MD
APHP, Hopital Avicenne, Service Hepatologie et Oncologie Hépatique
Bobigny, 93000
Nathalie GANNE, MD, 33 (0)1.48.02.66.66, nathalie.ganne@aphp.fr
Nathalie GANNE, MD
CHU Brest, Hopital de la Cavale Blanche Service Gastro-enterologie
Brest, 29609
Noemi REBOUX, MD, noemi.reboux@chu-brest.fr
Noemi REBOUX, MD
CHU de Caen, Hopital de la Cote de Nacre, Service Hepato-Gastro-Enterologie et Nutrition
Caen, 14033
Isabelle OLLIVIER-HOURMAND, MD, 33 (0)2.31.06.45.44, ollivierhourmand-i@chu-caen.fr
Isabelle OLLIVIER-HOURMAND, MD
CHU Trousseau Chambray, Service Gastro-enterologie et hepatologie
Chambray-lès-Tours, 37170
Helene BARRAUD, MD, 33 (0)2.47.47.59.16, h.barraud@chu-tours.fr
Helene BARRAUD, MD
CHU Dijon, Service Hepato-gastroenterologie et cancerologie digestive
Dijon, 21079
Anne MINELLO, MD, 33 (0)3.80.29.37.50, anne.minello@chu-dijon.fr
Anne MINELLO, MD
CHRU de Lille, Hopital Claude Huriez, Service des maladies de l'appareil digestif et de la nutrition
Lille, 59037
Alexandre LOUVET, MD, alexandre.louvet@chru-lille.fr
Alexandre LOUVET, MD
CHU Limoges, Hopital Dupuytren, Service Hepato-gastroenterologie et nutrition
Limoges, 87042
Marilyne DEBETTE-GRATIEN, MD, 33 (0)5.55.05.66.21, marilyne.gratien@chu-limoges.fr
Marilyne DEBETTE-GRATIEN, MD
CHU Hopital Edouard Herriot, Service Hepato-gastro-enterologie
Lyon, 69003
Jerome DUMORTIER, MD, 33 (0)4.72.11.01.09, jerome.dumortier@chu-lyon.fr
Jerome DUMORTIER, MD
CHU Lyon, Hopital Croix Rousse, Service Hepato-gastro-enterologie
Lyon, 69317
Teresa Maria ANTONINI-MICHELLE, MD, teresa.antonini@chu-lyon.fr
Teresa Maria ANTONINI-MICHELLE, MD
Hopital Saint Joseph, Service Hepato-gastro-enterologie
Marseille, 13285
Olivia PIETRI, MD, 33 (0)4 91 80 70 61, opietri@hopital-saint-joseph.fr
Olivia PIETRI, MD
CHU Montpellier, Hopital Saint Eloi, Service Hepato-gastro-enterologie
Montpellier, 34295
Lucy MEUNIER, MD, 33 (0)4.67.33.66.33, lucy.meunier@chu-montpellier.fr
Lucy MEUNIER, MD
CHU Nice, Hopital de l'Archet 2, Service Hepatologie
Nice, 06200
Rodolphe ANTY, MD, 33 (0)4.92.03.63.85, anty.r@chu-nice.fr
Rodolphe ANTY, MD
CHU Orleans, Hopital de la Source, Service Gastro-enterologie et hepatologie
Orléans, 45100
Pascal POTIER, MD, 33 (0)2.38.22.96.43, pascal.potier@chr-orleans.fr
Pascal POTIER, MD
AP-HP, Hopital St Antoine, Service Hepato-gastro-enterologie
Paris, 75012
Olivier CHAZOULLIERES, MD, 33 (0)1.49.28.29.23, olivier.chazouilleres@aphp.fr
Olivier CHAZOULLIERES, MD
APHP, Hopital Pitie-Salpetriere, Service d'hepatologie et de gastroenterologie
Paris, 75013
Marika RUDLER, MD, 33 (0)1.42.17.56.91, Marika.rudler@aphp.fr
Marika RUDLER, MD
AP-HP, Hopital Cochin Service Hepatologie
Paris, 75014
Charlotte MOULIADE, MD, charlotte.mouliade@aphp.fr
Charlotte MOULIADE, MD
CHU Bordeaux, GH Sud Haut-Leveque, Service Hepato-gastro-enterologie
Pessac, 33604
Victor DE LEDINGHEN, MD, 33 (0)5.57.65.64.39, victor.deledinghen@chu-bordeaux.fr
Victor DE LEDINGHEN, MD
CHU La Miletrie, Service Hepato-gastro-enterologie
Poitiers, 86000
Christine SILVAIN, MD, 33 (0)5.49.44.44.38, c.silvain@chu-poitiers.fr
Christine SILVAIN, MD
CHU Reims, Hopital Robert Debré, Service Hepato-Gastroenterologie et de Cancerologie digestive
Reims, 51092
Alexandra HEURGUE-BERLOT, MD, 33 (0)3.26.78.78.78, aheurgue@chu-reims.fr
Alexandra HEURGUE-BERLOT, MD
CHU de Rennes, Hopital de Pontchaillou, Service Maladie du foie
Rennes, 35000
Pauline HOUSSEL-DEBRY, MD, 33 (0).99.28.42.98, pauline.houssel-debry@chu-rennes.fr
Pauline HOUSSEL-DEBRY, MD
CHU Rouen, Service d'hepatogastro-enterologie
Rouen, 76031
Odile GORIA, MD, Odile.Goria@chu-rouen.fr
Odile GORIA, MD
CHU Strasbourg, Hopital de Hautepierre, Service Hepato-gastro-enterologie
Strasbourg, 67200
Camille BESCH, MD, 33 (0)3.88.12.74.48, camille.besch@chru-strasbourg.fr
Camille BESCH, MD
CHU Toulouse, Hopital Rangueil, Service Hepatologie
Toulouse, 31059
Christophe BUREAU, MD, 33 (0)5.61.77.25.27, bureau.c@chu-toulouse.fr
Christophe BUREAU, MD
AP-HP, Paul Brousse Hospital, Centre Hepato-Biliaire
Villejuif, 94800
Eleonora DE MARTIN, MD, PhD, 33 (0)1.45.59.64.33, eleonora.demartin@aphp.fr
Eleonora DE MARTIN, MD, PhD
About this study
Official title: Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study
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).
Read more
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.
Read the 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.
- Being tested
- Corticosteroid therapy
- Keywords
- Acute Severe AutoImmune Hepatitis (ASAIH), Decisional score, Prognostic score
- Medical subject headings
- Liver Failure, Acute, Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid therapyOther
Administration of high doses of corticosteroids as early as possible. Patient non-responder to treatment should lead to listing for emergency liver transplantation (LT).
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid therapy | Experimental | 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. Receives: Other: Corticosteroid therapy |
| Patient without corticosteroid therapy | No intervention | Patient not treated will undergo to emergency Liver Transplantation (LT) or death. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90
Secondary outcomes (8)
The association between infection occurrence and death during hospitalization
Documented infections during hospitalization
Measured: participation period (treatment+follow-up): 12 months
the management of infected ASAIH patients in usual practice
Antibiotic therapy : doses
Measured: participation period (treatment+follow-up): 12 months
The risk factors for early AIH flair after corticosteroid therapy response.
The frequency of AIH flair
Measured: D90
The risk factors for AIH recurrence after liver transplantation
AIH recurrence
Measured: participation period (treatment+follow-up): 12 months
The evolution of patients after LT
Retransplantation, alive, death
Measured: participation period (treatment+follow-up): 12 months
The evolution of patients not treated with corticosteroids but meeting the inclusion and non-inclusion criteria
Retransplantation, alive, death
Measured: participation period (treatment+follow-up): 12 months
The prognostic factors for survival in patients treated with corticosteroids who underwent or not LT
quality of the graft, immunosuppression, rejection episode,
Measured: participation period (treatment+follow-up): 12 months
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jun 2024 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Failure, AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleonora DE MARTIN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473403
- Sponsor's protocol ID
- D20180121
- Other IDs
- 2021-A01869-32
- Acronym
- PRO-SURFASA
- Status last verified
- Sep 2023
- First submitted
- 7 Jun 2022
- Last updated
- 13 Mar 2024
- Results posted
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis, a National Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT05473403
- Acronym / sponsor ID
- PRO-SURFASA / D20180121
- Keywords
- Acute Severe AutoImmune Hepatitis (ASAIH), Decisional score, Prognostic score
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Jul 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid therapy | Experimental | Other: Corticosteroid therapyPrednisone 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 without corticosteroid therapy | No intervention | –Patient not treated will undergo to emergency Liver Transplantation (LT) or death. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
- Use of corticosteroids 1 month before inclusion
- Pregnant or lactating woman
- Curator or guardianship or patient placed under judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid therapyAdministration of high doses of corticosteroids as early as possible. Patient non-responder to treatment should lead to listing for emergency liver transplantation (LT). | Other | Corticosteroid therapy |
Primary outcome
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.
Time frame: Day 90
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.
8 secondary outcomes
The association between infection occurrence and death during hospitalization
Time frame: participation period (treatment+follow-up): 12 months
the management of infected ASAIH patients in usual practice
Time frame: participation period (treatment+follow-up): 12 months
The risk factors for early AIH flair after corticosteroid therapy response.
Time frame: D90
The risk factors for AIH recurrence after liver transplantation
Time frame: participation period (treatment+follow-up): 12 months
The evolution of patients after LT
Time frame: participation period (treatment+follow-up): 12 months
The evolution of patients not treated with corticosteroids but meeting the inclusion and non-inclusion criteria
Time frame: participation period (treatment+follow-up): 12 months
The prognostic factors for survival in patients treated with corticosteroids who underwent or not LT
Time frame: participation period (treatment+follow-up): 12 months
The association of histological features (liver biopsy) with response to corticosteroids and survival at 90 days since admission
Time frame: 90 days
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 13 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Liver Failure, Acute
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Eleonora DE MARTIN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid therapy in people with Liver Failure, Acute and Hepatitis, Autoimmune, run by Assistance Publique - Hôpitaux de Paris at 26 sites 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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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 Eleonora DE MARTIN, MD, PhD (33 (0)1.45.59.64.33, eleonora.demartin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 90). 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 13 Mar 2024.