Overview

Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for clinicians involved in the management of severe alcoholic liver disease. In patients with Maddrey function higher than 32, compelling evidence from data has shown that corticosteroids improve short-term survival. However, novel strategies or molecules are required in light of the fact that approximately 40 % of patients continue to die at 6 months. A double-blinded randomized controlled trial of 101 patients has showed that Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal function whereas corticosteroids induce an early improvement in liver function. When considering these differences of mechanisms, many clinicians suggest that the addition of pentoxyfilline to corticosteroids is an attractive option that needs to be tested in patients with severe AH.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Lille
Collaborator:
Ministry of Health, France
Treatments:
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Pentoxifylline
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate