NCT06956482View on ClinicalTrials.gov

PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

477

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

October 31, 2026

Conditions
Alcoholic Hepatitis
Interventions
DRUG

N-Acetylcysteine (NAC) Treatment

N-acetylcysteine for five days (day 1 to day 5) at a daily dose of 300mg/Kg

DRUG

Prednisolone

prednisolone 40 mg/day for a total of 30 days

DRUG

Placebo of N-acetylcysteine

Placebo of N-acetylcysteine for five days (day 1 to day 5)

DRUG

Placebo of Prednisolone

Placebo of prednisolone for 30 additional days

DRUG

Prednisolone

prednisolone (tapering dose) for 30 additional days

All Listed Sponsors
lead

University Hospital, Lille

OTHER