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NCT06155760

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

Status unknown NA Last updated 4 December 2023
What this trial tests

NA trial testing Prednisolone in Severe Alcoholic Hepatitis in 150 participants. Status unknown.

Timeline
25 November 2023
Primary endpoint
27 February 2025
27 February 2025

Quick facts

Lead sponsorInstitute of Liver and Biliary Sciences, India
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment150
Start date25 November 2023
Primary completion27 February 2025
Estimated completion27 February 2025
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 60, any sex, with Severe Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current Clinical Trials for Alcohol-Associated Hepatitis.
    Rady ED, Anouti A, Mitchell MC, Cotter TG. · · 2026 · cited 3× · PMID 40254132 · DOI 10.1016/j.ajpath.2025.03.009
  2. Alcohol-Associated Hepatitis: Translating Pathophysiology into Targeted Clinical Trials.
    Ma J, Gao H, Zeng G, Huda N, et al · · 2025 · PMID 41163775 · DOI 10.1007/s11901-025-00703-9

Verify or expand the search:

Other trials of Prednisolone

Trials testing the same drug.

Other Institute of Liver and Biliary Sciences, India trials

Trials by the same sponsor.

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Data sources for this page

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