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Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis

NCT06155760 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-12-04

No results posted yet for this study

Summary

Severity of alcoholic hepatitis is defined by Maddrey's discriminant function, value of 32 or higher indicates severe alcoholic hepatitis that carries an adverse prognosis with one month mortality of 30%-50%. Prednisolone (40 mg/day) given orally should be considered to improve 28-day mortality in patients with severe AH. Abstinence is key to long-term survival.

According to current protocol, we discontinue the treatment after 28 days but only 15 % patient is achieving the DF \< 32 after 28 days of treatment.

The aim of this study is to evaluate the role of extended low dose prednisolone (10mg) in achieving remission by day-90 in steroid responsive severe alcoholic hepatitis.

Conditions

  • Severe Alcoholic Hepatitis

Interventions

DRUG

Prednisolone

10mg of prednisolone plus standard medical therapy for 60 days

OTHER

Standard Medical therapy

IV Albumin, Diuretics, Multi vitamins as per clinicians decision

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-11-25
Primary Completion
2025-02-27
Completion
2025-02-27

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT06155760 on ClinicalTrials.gov