← Eichor
Study identifier: NCT06956482 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

Condition: Alcoholic Hepatitis  ·  Sponsor: University Hospital, Lille

PhasePhase 3
Planned participants477
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Only patients suffering from a severe form of alcoholic hepatitis (Maddrey's discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients still have a bad outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score \< 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders by a Lille score greater than 0.56. In them, there is a consensus for stopping prednisolone after a 7-day course of treatment (Lille score is calculated after 7 days) while patients with a Lille score \<0.56 continue treatment for a total of 30 days. Numerous trials have attempted to test the impact of other strategies in association with prednisolone, but none of them has shown an improvement in survival (primary endpoint) as compared to prednisolone alone. These strategies include for instance pentoxifylline, amoxicillin-clavulanic acid and enteral nutrition. Because oxidative stress is a…

This description comes directly from the study's public registry record.

Talk to the study team

Alexandre Louvet, Prof.  ·  +33 (0)3 20 44 53 03  ·  alexandre.louvet@chu-lille.fr

Always discuss trial participation with your own doctor first.

Locations (1)

CHU de Lille, Hôpital HuriezLille, FranceRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06956482