Corticosteroids in Alcoholic Hepatitis

NCT03160651 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-02-26

No results posted yet for this study

Summary

Approximately 50% of patients admitted for severe AH will have spontaneous improvement of liver function before initiation of therapy (ie decrease in mDF between hospital admission and initiation of steroids). These patients have a better prognosis than patients without spontaneous improvement of liver function. It has never been demonstrated that corticosteroids improve survival in severe AH patients with spontaneous improvement of liver function. Our hypothesis is that severe AH patients with spontaneous improvement of liver function represent a group who could most benefit from steroids

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

Methylprednisolone or placebo

Patients will receive 28 days of methylprednisolone 32 mg/day

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Christophe Moreno, MD, PhD · Erasme University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Belgium

Study Locations

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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 NCT03160651 on ClinicalTrials.gov