NCT03160651.

Trial name or title	Corticosteroids in severe alcoholic hepatitis patients with early spontaneous improvement
Methods	Interventional (clinical trial). Double‐blind randomised trial: Investigator, participants, and care providers will be masked. Only statisticians and pharmacist will not be masked.
Participants	Participants with alcoholic hepatitis: aged ≥ 18 years of either sex Inclusion criteria: clinical syndrome of alcoholic hepatitis; recent jaundice or in recent aggravation (< 3 months), serum bilirubin > 5 mg/dL, history of excess alcohol abuse (> 40 g/day); alcoholic hepatitis confirmed by liver biopsy (histological criteria of alcoholic hepatitis defined according to EASL clinical practice guidelines: steatosis, hepatocyte ballooning, and an inflammatory infiltrate with PMNs); spontaneous liver function improvement, defined by a decrease in Maddrey Discriminant Function and serum bilirubin > 10% between admission and day 7 after admission < 2 weeks since admission to hospital; Maddrey Discriminant Function ≥ 32; people must voluntarily sign and date an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee prior to the initiation of any screening or study‐specific procedures; be able to understand and adhere to the study visit schedule and all other protocol requirements; people with significant hepatic encephalopathy will not be excluded. In this case, the person should be accompanied by a legal representative who will decide participation in the clinical study and sign informed consent form. Exclusion criteria: other causes of liver disease including viral hepatitis (positive hepatitis B surface antigen, HCV RNA positive), autoimmune hepatitis, biliary obstruction; other disease compromising 90‐day survival; positive HIV serology; uncontrolled infection. All participants will be screened for infection involving chest radiography, urinalysis, PMNs count in ascites (if ascites present). All other sign or clinical suspicion of infection with or without antibiotherapy will be recorded as an infection. Positive culture and initiation of antibiotics with clinical or radiological signs of infection, as well as clinical suspicion, will be recorded as infection. People with evidence of sepsis will be treated for a minimum of 2 days with appropriate antibiotics. Once the local principal investigator considers that the sepsis is under control, the person may be rescreened and randomised. Uncontrolled gastrointestinal bleeding judged as controlled for ≥ 5 days; serum creatinine > 2.5 mg/dL, under renal replacement therapy or under terlipressin (or other vasoactive drugs); pentoxyphilline therapy; pregnant or lactating women
Interventions	Parallel assignment of methylprednisolone or placebo Active comparator: methylprednisolone: methylprednisolone 32 mg/day for 28 days Placebo comparator: matching placebo for 28 days
Outcomes	Primary outcomes Mortality at 90 days Secondary outcome Mortality at 28 days Incidence of infections during the study period (90 days)
Starting date	Estimated study start date: June 2017
Contact information	Contact: Christophe Moreno, MD, PhD +32 2 5553714christophe.moreno@erasme.ulb.ac.be Contact: Françoise Smits, Nurse +32 2 5554478francoise.smits@erasme.ulb.ac.be Sponsors and collaborators: Erasme University Hospital Principal investigator: Christophe Moreno, MD, PhD; Erasme University Hospital
Notes	Estimated primary completion date: June 2020 Estimated study completion date: January 2021

EASL: European Association for the Study of the Liver; HCV: hepatitis C virus; MDF: Maddrey's Discriminant Function; PMN: polymorphonuclear neutrophil.