drugset / Trial / NCT06155760

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

NCT06155760

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified 10 mg Oral

Indications