Actively Recruiting
Short Course Steroids in Alcohol Associated Hepatitis
Led by Asian Institute of Gastroenterology, India · Updated on 2025-04-17
146
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Asian Institute of Gastroenterology, India
Lead Sponsor
M
Mahatma Gandhi Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Short Course Steroids in Alcohol Associated Hepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Alcohol-Associated Hepatitis aged between 18 and 80 years with MELD score >21 and/or Maddrey's Discriminant Function >32
- Patients with controlled infection at baseline defined as afebrile for at least 48 hours, sterile cultures, and procalcitonin < 1 ng/ml
You will not qualify if you...
- Younger than 18 years or older than 80 years
- Active infection at enrollment
- Persistent acute kidney injury (creatinine >1.5 mg/dl) or chronic kidney disease
- Recent or ongoing bleeding
- Active peptic ulcer disease
- Presence of hepatocellular carcinoma, portal vein thrombosis, or hepatic venous outflow tract obstruction
- Other liver diseases including hepatitis B or C
- HIV infection
- Uncontrolled diabetes mellitus
- Current treatment with pentoxifylline or N-acetylcysteine (NAC)
- Unwillingness to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
AIG Hospitals
Hyderabad, Telangana, India, 500032
Actively Recruiting
2
AIG
Hyderabad, Telangana, India, 500035
Actively Recruiting
Research Team
A
ANAND KULKARNI V DR. ANAND V KULKARNI, SENIOR CONSULTANT
CONTACT
S
Sridevi prasanna daparti, DR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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