Short Course Steroids in Alcohol Associated Hepatitis

Launched by ASIAN INSTITUTE OF GASTROENTEROLOGY, INDIA · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of short courses of steroids to treat alcohol-associated hepatitis (AAH), a serious liver condition caused by heavy drinking. Researchers want to find out if taking a lower dose of the steroid prednisolone for a shorter period can help patients just as much as the standard treatment, which lasts longer. In this study, some participants will receive prednisolone for just 7 days, followed by a placebo (a dummy treatment) for another week, while others will take the steroid for 14 days. The goal is to see how these treatments affect infection rates, survival, and any side effects.

To participate in this trial, you need to be between 18 and 80 years old and diagnosed with severe AAH. There are some health conditions that would prevent you from joining, such as uncontrolled infections or certain liver diseases. If you join, you will be closely monitored for any signs of infection or side effects, and your treatment will be adjusted as needed. This trial is actively recruiting participants, and it's an important step toward improving care for individuals suffering from this challenging condition.

Gender

ALL

Eligibility criteria

• 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