Short Course Steroids in Alcohol Associated Hepatitis (NCT06919458) | Clinical Trial Compass
RecruitingPhase 3
Short Course Steroids in Alcohol Associated Hepatitis
India146 participantsStarted 2025-04-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with AAH aged between 18 and 80 years with a MELD score \>21 and/or mDF \>32 will be included.
* Patients with infection at baseline will be included if they have controlled infection defined as afebrile for at least 48 hours, sterile cultures and procalcitonin \< 1 ng/ml.
Exclusion Criteria:
* Age \< 18 years, \> 80 years
* Active Infection
* Persistent acute kidney injury (creatinine \>1.5 mg/dl) or chronic kidney disease
* Recent/ongoing bleed
* Active peptic ulcer disease
* Hepatocellular carcinoma, portal vein thrombosis or hepatic venous outflow tract obstruction
* Patients with concomitant other liver diseases including hepatitis B, C
* Patients with HIV
* Uncontrolled diabetes mellitus
* Patients on pentoxifylline or NAC
* Patients who are unwilling
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants developing infection in each group
Timeframe: at day 28 and 90
Trial details
NCT IDNCT06919458
SponsorAsian Institute of Gastroenterology, India
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-04-08
Contact for this trial
ANAND KULKARNI V DR. ANAND V KULKARNI, SENIOR CONSULTANT