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Can 7 days of steroids beat 14 for Alcohol-Related liver disease?

NCT ID NCT06919458

Disease control Sponsor: Asian Institute of Gastroenterology, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This phase 3 trial compares two steroid schedules for severe alcohol-associated hepatitis, a serious liver condition with high death rates. One group takes prednisolone for 7 days followed by a placebo for 7 days, while the other takes prednisolone for the full 14 days. Researchers want to see if the shorter course reduces infections while keeping the treatment effective. The study includes 151 adults with severe disease and tracks infections, survival, and side effects for 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prednisolone (a corticosteroid)
What this could lead to
If a shorter steroid course works as well as the standard one, it could reduce infections and improve survival for people with severe alcohol-associated hepatitis.
What could go wrong
The trial is still recruiting and results are not in. Shorter treatment might be less effective, and steroids carry risks like infection and poor blood sugar control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

151 people

The number who actually took part.

Started

Apr 2025

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcoholic hepatitis

Contacts and locations

Locations

  • AIG

    Hyderabad, Telangana, 500035, India

  • AIG Hospitals

    Hyderabad, Telangana, 500032, India

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