MedTrace Logo

Short Course Steroids in Alcohol Associated Hepatitis

NCT06919458 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

Prednisolone 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.

Sponsors & Collaborators

  • Mahatma Gandhi Medical College

    collaborator OTHER

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER

  • Kalinga Institute of Medical Sciences, Bhubaneswar

    collaborator UNKNOWN

  • Apollo Gleneagles Hospitals, Kolkata

    collaborator OTHER

  • Asian Institute of Gastroenterology, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-04-08
Completion
2026-04-08

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06919458 on ClinicalTrials.gov