Short Course Steroids in Alcohol Associated Hepatitis

Recruiting now · Phase 3

Conditions studied: Alcoholic Hepatitis

In brief

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.

Key facts

Study ID

NCT06919458

Run by

Asian Institute of Gastroenterology, India

People needed

146

Starts

2025-04-07

Expected to finish

2026-04-08

Last updated by the study team

2025-04-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• AIG Hospitals — Hyderabad, Telangana, India (enrolling)
• AIG — Hyderabad, Telangana, India (enrolling)

Full record on ClinicalTrials.gov

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