RecruitingPhase 3NCT06919458

Short Course Steroids in Alcohol Associated Hepatitis

Seven Day Versus Fourteen-day Corticosteroid in Patients With Severe Alcohol -Associated Hepatitis- A Double Blind Randomized Controlled Trail (STASH II)

Sponsor

Asian Institute of Gastroenterology, India

Enrollment

146 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Alcoholic Hepatitis

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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 Criteria11

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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Interventions

DRUGPrednisolone 40 mg

Patients will be screened for infection till 90 days from the day of initiation of prednisolone. the three patient arms will be compared for severity scores of the disease, rate and severity of infections, diabetic control, post-treatment outcomes, and mortality.