Short Course Steroids in Alcohol Associated Hepatitis

Alcohol-associated hepatitis (AAH) is one of the most severe manifestations of the spectrum of alcohol related liver disease (ARLD), with high morbidity and mortality. Currently, corticosteroids are the standard of care for patients with severe AAH, but no consensus exists on the dosing schedule of steroids. The investigators have recently demonstrated that tapering prednisolone over 4 weeks reduces the risk of infections at day 90. However, the investigators wanted to test whether the reduction in the duration of therapy would provide a similar benefit as tapering the dose of prednisolone. Therefore, the investigators planned to assess the impact of a shorter duration of prednisolone on outcomes, including the incidence of infections, survival and adverse events. One group will receive 7 days of prednisolone followed by a placebo for the next seven days, and the other group will receive 40 mg of prednisolone for 14 days. Prednisolone will be stopped in case of non-response and/or adverse events to the drug. All infections will be diagnosed by an ID specialist who is blind to the allocated group.

NCT Number	NCT06919458
Lead Sponsor	Asian Institute of Gastroenterology, India Collaborators: Mahatma Gandhi Medical College, Post Graduate Institute of Medical Education and Research, Chandigarh, Kalinga Institute of Medical Sciences, Bhubaneswar, Apollo Gleneagles Hospitals, Kolkata
Conditions	Alcoholic Hepatitis
Enrollment	146 participants
Start Date	2025-04-07
Primary Completion	2026-04-08 (estimated)
Study Completion	2026-04-08 (estimated)
Updated on ClinicalTrials.gov	2025-04-17